This guidance is limited to devices used to manage cardiac rhythms known as cardiac implanted electronic devices (CIED), including pacemakers, ICD and CRT. Cardiac assist devices such as LVADs and BiVADs are not included.

You should read this document in conjunction with guidance on post market surveillance.

The aim of this guidance is to complement the requirements of SI 2024 No.1368. You should read it in conjunction with this regulation. Device specific guidance does not replace or extend these requirements.

What should be reported

The following examples indicate how to report device performance problems that caused or contributed to an incident. The examples are for illustrative purposes only and do not constitute an exhaustive list.

If in an incident appears to meet criteria contained in more than one category, ensure it is included in submissions under each reporting format, even if this results in duplication of reporting for that incident.

The IMDRF annex codes associated with each text description are included as guides.

Report as individual incidents (in line with statutory reporting timescales)

Clinical / Symptomatic (IMDRF Annex E codes)

death (E0602), unless information or evaluation of device indicates not device related
tamponade due to cardiac perforation (E0605)
pericardial effusion when pericardiocentesis or surgery is needed (E0619)
pneumothorax (E0734)
major/severe bleeding due to great vessel perforation (E051101)
bleeding (E0506)
prolonged asystole (E060101)
life-threatening arrhythmia requiring resuscitation (E0601)

Device (IMDRF Annex A codes)

undersensing by ICD/lead – failure to deliver programmed defibrillation/ anti- tachycardia pacing therapy (A070910)
loss of capture/ stimulation post implant not resolved by reprogramming or repositioning (to address a threshold rise) (A0701)
inability to deliver programmed high voltage therapy (A071301)
oversensing: by ICD/lead – causing inappropriate shock or anti-tachycardia pacing unless evidence exists that it is due to electromagnetic interference (A070909)
loss of output (other than normal battery depletion) (A070908 / A090405 / A070801)
lead impedance rise due to suspected conductor fracture (A0722)

Pacing impedance is typically considered abnormal if a measurement is <200 Ω or >1000-3000 Ω (depending on the lead model). Defibrillation impedance is typically considered abnormal if a measurement is < 20 Ω or > 200 Ω. (based on lead model and measurement range of the device)

delivery system failure with the potential to lead to a serious injury e.g. leadless device (A071301)
dislodgement of leadless device post implant (A051201)
programmer problem with the potential to cause serious injuries (A2202)

Incidents that may be included in periodic summary reports (PSR) on agreement

If you can’t use PSR, then report these events individually.

Clinical / Symptomatic (IMDRF ANNEX E codes)

pericardial effusion due to pericardial and/or myocardial perforation (without tamponade) (E0619). To be reported on a 3 monthly basis.

Device (IMDRF ANNEX A codes)

a) To be reported on a 3 monthly basis:

pacing: undersensing (risk of competitive pacing) not resolved by reprogramming (A070910)
pacing: oversensing/ noise suspected to be related to a lead malfunction (A070909)
premature/unexpected battery depletion (A070504)
lead impedance drop due to suspected insulation failure (A0722)

b) To be reported on a 6 monthly basis:

lead – pulse generator disconnection or set screw problem which leads to re-opening of the pocket (A071209)
reversion to back-up VVI mode when not designed to do so (ventricle paced, ventricle sensed, pacing inhibited) (A071205)
persistent telemetry problems in-clinic (interrogation or programming) (A1304)
remote monitoring issues (software or device related) (A1103)

Report at the time of a statistically significant increase in the frequency or severity of incidents

Clinical / Symptomatic (IMDRF ANNEX E codes)

pocket or other device-related infection (E1906)
cerebrovascular accident (stroke and transient ischemic attack) (E013302)
other thromboembolic complications (E050304)

Device (IMDRF ANNEX A codes)

electrode displacement / dislodgement (A051201)
programmer problem without the potential to cause serious injuries (A2202)
all set screw/connection problems irrespective of patient impact (A1208)
loss of capture/ stimulation post implant resolved by repositioning (to address a threshold rise) (A0701)

Clinical reference guidelines

Clinical reference guidelines for a specific device may be of use to manufacturers when identifying incident examples and complications.

Current clinical guidelines for CIED procedures, expert consensus statements and current analysis of complications have been published by the European Society of Cardiology.

Clinical Service Guidelines for the United Kingdom have been published by the British Heart Rhythm Society

Device specific vigilance guidance: Cardiac Implantable Electronic Devices (CIEDs)