Primo MRI™ VR SureScan™ DVMD3D1Recalls & reported problems
Medtronic, Inc. · ICD-VR DVMD3D1 PRIMO MRI US · Class 3 · Implant
All models of Primo MRI VR SureScan (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000001537), received between Dec 22, 2021 and Jul 11, 2025 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 10, 2023Class IOpen, Classified
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Z-1814-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Electrical /Electronic Property Problem1
- Impedance Problem1
- Mechanical Problem1
- Over-Sensing1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Discomfort1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2025Over-Sensing; Impedance Problem; Over-Sensing; Impedance Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A LEAD INTEGRITY ALERT (LIA) FOR ELEVATED SENSING INTEGRITY COUNTER (SIC) AND PACING IMPEDANCE SPIKES SUSPECTED TO BE IN RELATION TO INTERACTION WITH THE PATIENT¿S CARDIAC CONTRACTILITY MODULATION (CCM) DEVICE. 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 22482033 ↗InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THAT ONE MONTH AFTER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED, THE PATIENT DEVELOPED A POCKET INFECTION FROM THE GENERATOR CHANGE OUT. THE ICD SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 16108302 ↗MalfunctionOct 27, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT AT IMPLANT ATTEMPT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR'S (ICD'S) SET SCREW WOULD NOT ENGAGE AND HOLD IN PLACE ON A PIN PLUG FOR A COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD. THE ICD WAS EVENTUALLY NOT USED IN THE IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15680674 ↗InjuryFeb 1, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAD A POCKET REVISION DUE TO DISCOMFORT. THE SAME DAY AS THE REVISION THERE WAS A LEAD INTEGRITY AL ERT (LIA) TRIGGERED BY HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). THREE WEEKS LATER ANOTHER LIA OCCURRED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Discomfort
MAUDE report 13416397 ↗MalfunctionDec 22, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT PRIOR TO IMPLANT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INTERROGATED AND DISPLAYED A GRAY BAR INSTEAD OF A NUMERICAL VALUE FOR THE BATTERY LONGEVITY ESTIMATION. THE ICD WAS NOT IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13060065 ↗
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 reports
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 · each recall links to the FDA recall notice
- 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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