ISO 5841-2:2014 手術用インプラント—心臓ペースメーカー—パート2：パルス発生器またはリードの母集団の臨床成績の報告 | ページ 6

3.1

advisory notification

<of a device> any action taken to inform the clinicians concerned by a manufacturer who has become aware that a device might fail to conform to any claims made relating to effectiveness, benefits, performance characteristics, or safety

3.2

clinical performance period

calendar period, defined by the reporting party, during which the clinical performance of a specific population sample of devices is assessed

3.3

complaint

any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution^[15]

3.4

confirmed malfunction

malfunction of an implanted device, confirmed by returned product analysis, not including induced malfunctions

3.5

damaged

<of a device> having characteristics which have changed outside the limits stated by the manufacturer, due to some external agency

3.6

device

cardiac pulse generators or leads, intended for long-term implantation

3.7

device family

specified group of device model numbers with the same indications for use and designs that differ only with respect to parameters not reasonably expected to significantly affect malfunction incidence or longevity, such as pulse generator header differences or lead length

3.8

follow-up centre

medical centre, hospital, clinic, or individual responsible for the care of a patient after the implantation of a device

3.9

implanted

status of a device after the surgical incisions are closed (implant pocket closed); if relevant clinical details are not available to the manufacturer, at least one calendar day shall have passed after the implant date in order to classify the device as implanted

3.10

implant damage — leads

damage which occurred after opening the lead package and during an attempt to implant the lead, i.e. the implant was not completed using the lead in question

3.11

induced malfunction — pulse generators

device malfunction caused by external factors (e.g. therapeutic radiation, excessive physical damage, etc.) including but not limited to hazards addressed in product labeling

Note 1 to entry: Damage to a pulse generator caused by a lead malfunction will be reported as a lead malfunction.

3.12

induced malfunction — leads

lead malfunction caused by use error or other external factors (e.g. scalpel cuts, damage caused during implant, sutures applied directly to lead body, explant or after explant etc.) including applications outside of labeling recommendations or addressed in product labeling as cautions or hazards in product labeling

Note 1 to entry: Damage to a lead caused by a pulse generator malfunction will be reported as a pulse generator malfunction.

3.13

in service

<of a device> functioning in such a manner as to provide potential medical benefits to the patient

Note 1 to entry: This term can apply to a device that may be out of specification (see 3.23).

3.14

in specification

<of a device> having characteristics within the limits recommended by the manufacturer for clinical use

3.15

lead modified — electrically

lead that remains connected to a pulse generator whose function is automatically altered or manually reprogrammed (e.g. changing from bipolar to unipolar or DDD to VVI mode) in response to a problem with the mechanical or electrical integrity of the lead

3.16

lead modified — surgically

any mechanical alteration of the lead (e.g. replacing a connector or the rate sensing portion of an ICD lead) in response to a problem with the mechanical or electrical integrity of the lead

Note 1 to entry: Does not include leads that have been successfully repositioned.

3.17

malfunction

failure of a device to meet its performance specifications or otherwise perform as intended

Note 1 to entry: Performance specifications include all claims made in the labelling for the device. The intended performance of a device refers to the intended use for which the device is labelled or marketed.^[14]

3.18

malfunction without compromised therapy — pulse generator

pulse generator malfunction that did not compromise pacing or defibrillation therapy while implanted and in service

Note 1 to entry: Therapy is not compromised as long as the critical patient-protective pacing and defibrillation therapies are available. This includes changes in device settings that occur as intended by the design and do not result in loss of critical patient protective therapies but are the reported reasons for explant. Examples include (but are not limited to): reversion to a designed ”safe mode”, ”backup mode”, ”power-on reset” or other manufacturer-specific terminology, error-affecting diagnostic functions, telemetry function, data storage, malfunction of a component that causes battery to lose power quickly enough to cause premature battery depletion, but slowly enough that the condition is detected through normal follow-up before therapy is lost; mechanical problems with connector header that do not affect therapy.

3.19

malfunction with compromised therapy

device malfunction causing compromised pacing or defibrillation therapy (including complete loss or partial degradation) while implanted and in service

3.20

medical reasons

reasons unrelated to the device or its operation

Note 1 to entry: Examples include (but are not limited to):Infection, extrusion, indication for an alternative medical device (e.g. the replacement of a single-chamber pacemaker in a patient with pacemaker syndrome with a dual-chamber pacemaker), etc.

3.21

normal battery depletion

for pulse generators, the condition when (a) a device is returned with no associated complaint and the device has reached its elective replacement indicator(s) with implant time that meets or exceeds the nominal (50 percentile) predicted longevity at default (labeled) settings, or (b) a device is returned and the device has reached its elective replacement indicator(s) with implant time exceeding 75 % of the expected longevity using the longevity calculation tool available at time of product introduction, calculated using the device’s actual use conditions and settings

3.22

other conditions affecting performance — leads

non-electrical findings which do not affect clinical usage or outcomes, but might, for example, influence the length of a procedure

Note 1 to entry: Anomalous findings are those occasions where lab analysis reveals a secondary finding on a returned lead. These findings are not associated with a complaint. Examples include evidence of partial insulation abrasion, no conductor exposed or other cosmetic issues. Lead may have been successfully implanted.

3.23

out of service

<of a device> not providing a medical benefit to the patient

Note 1 to entry: A device thus described is not necessarily out of specification (see 3.24) or explanted.

3.24

out of specification

<of a device> having one or more characteristics outside the limits established by the manufacturer for clinical use

3.25

population sample

group of devices that is assumed to be representative of the worldwide population of implanted devices

Note 1 to entry: Typically, devices registered as implanted in the United States can serve as the population sample, but other data sources can be utilized, including, but not limited to remote monitoring and clinical studies.

3.26

post-approval surveillance study

enrollment of a sample of patients in identified centers for the purpose of prospective, active, systematic, scientifically valid collection, analysis, and interpretation of data, or other information, collected to report on device performance

3.27

post-market surveillance

activity performed by a manufacturer to assess product performance using analysis of complaints and returned products

3.28

premature battery depletion

for pulse generators, the condition when a device is returned and confirmed to have depleted the battery in a time period less than normal battery depletion

3.29

product performance report

document published by a pulse generator or leads manufacturer intended to report long term clinical performance of individual products

3.30

production group

population sample of devices designated by the manufacturer on the basis of a particular parameter

3.31

prophylactic explantation

explantation for reasons based on the anticipated performance of the device or other medical reasons

3.32

recommended replacement condition

condition in which the device exhibits characteristic(s) identified by the manufacturer as signalling that the device should be taken out of service

3.33

registered explant

registered implant for which the date of explantation is known by the reporting party

3.34

registered implant

implanted device for which the date of implantation is known by the reporting party

3.35

registered implant month

one month of operation by a registered implant

3.36

reporting party

individual or organization publishing clinical pacemaker data or the analysis thereof