ANSI AAMI ISO 5841-2:2014 pdf download – Implants for surgery – Cardiac pacemakers
1 Scope
This part of ISO 5841 specifies requirements for reports on the clinical performance in humans of population samples of cardiac pulse generators or leads, intended for long-term implantation, hereinafter referred to as devices. Devices to be reported have to be market approved in one or more geographies. It includes general requirements for all reports and supplementary requirements for reports on cumulative experience with devices and estimates of future clinical performance for devices, when appropriate. Annex A provides requirements for categorizing devices. It also provides normative requirements for statistical calculations, including a discussion of application of the results obtained. As with other statistical methods, the benefit of the analytical methods in this part of ISO 5841 is limited by the size of population under consideration. Annex B gives the rationale for this part of ISO 5841 .
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 center
medical center, 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.
3.18 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.