Visia AF MRI™ S VR SureScan™ DVFC3D1 (UDI 00643169929944)Recalls & reported problems

Medtronic, Inc. · ICD-VR DVFC3D1 VISIA AF MRI S US DF1 · Class 3 · Implant

All models of Visia AF MRI S VR SureScan (7)

Data updated Oct 18, 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 00643169929944), received between Mar 16, 2023 and Jan 15, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Sensing Problem” (2 reports).

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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Sensing Problem2
Adverse Event Without Identified Device or Use Problem1
Inappropriate/Inadequate Shock/Stimulation1
Pacing Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1
Shock from Patient Lead(s)1
Unspecified Infection1

Recent adverse event reports

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

MalfunctionJan 15, 2025Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED ECTOPY WHICH WAS MISCLASSIFIED AS ATRIAL FIBRILLATION (AF). THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21159569 ↗
InjuryMar 28, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED VENTRICULAR FIBRILLATION (VF), DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED THE PATIENT. IT WAS SUSPECTED THAT THE RHYTHM WAS SUPRA VENTRICULAR TACHYCARDIA (SVT), THEREFORE THE THERAPY WAS INAPPROPRIATE . THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Shock from Patient Lead(s)
MAUDE report 18991522 ↗
InjuryMar 16, 2023Adverse 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 INFECTED. ADDITIONALLY, IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD VEGETATION PER AN ECHOCARDIOGRAM AND VENTRICULAR UNDERSENSING. THE ICD SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 16554276 ↗

Device details

UDI-DI	`00643169929944`
Brand	Visia AF MRI™ S VR SureScan™
Model	DVFC3D1
Company	Medtronic, Inc.
Product code	NVZ · Pulse generator, permanent, implantable
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	Not in Commercial Distribution
Record updated	Feb 5, 2021

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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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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