Evera™ S VR DVBC3D4 (UDI 00643169929876)Recalls & reported problems

Medtronic, Inc. · ICD-VR DVBC3D4 EVERA S US DF4 · Class 3 · Implant

All models of Evera S VR (8)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169929876), received between Aug 16, 2018 and Jun 28, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1
Electrical /Electronic Property Problem1
Mechanical Problem1
Premature Discharge of Battery1

Patient problems

No Known Impact Or Consequence To Patient2
Unspecified Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED FOR INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 14844338 ↗
MalfunctionDec 13, 2018Premature Discharge of Battery; Electrical /Electronic Property Problem; Premature Discharge of Battery; Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAS PREMATURE BATTERY DEPLETION. THE BATTERY LONGEVITY ESTIMATE WAS LESS THAN EXPECTED. THE DEVICE CONTINUES TO BE MONITORED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8162180 ↗
InjuryAug 16, 2018Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENTS RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) WITH INCREASED SENSING INTEGRITY COUNTER (SIC), HIGH RATE NON-SUSTAINED EPISODES, NOISE, HIGH THRESHOLDS, LOW DEFIB IMPEDANCE, AND NON-CAPTURE. IT WAS THOUGHT THAT THERE COULD BE A CONNECTION ISSUE IN WHICH THE LEAD HAD NOT BEEN FULLY INSERTED INTO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HEADER OR THE LEAD IS DISLODGED. A REVISION WAS COMPLETED AND THE DEVICE WAS EXTRACTED AND REPLACED, WHILE THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7789724 ↗

Device details

UDI-DI	`00643169929876`
Brand	Evera™ S VR
Model	DVBC3D4
Company	Medtronic, Inc.
Product code	LWS · Implantable cardioverter defibrillator (non-CRT)
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 1, 2025

Device type (GMDN): Single-chamber implantable defibrillator

An implantable pulse generator (IPG) with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), intended to deliver an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and typically to pace a slow heart rate. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected a lead(s) that are positioned inside or on one heart chamber (typically right ventricle) to monitor the ECG and to automatically deliver the electrical impulse. It has internal batteries that provide the energy for the discharges; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).

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All Implantable cardioverter defibrillator (non-CRT) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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