VictoryRecalls & reported problems across all models
St. Jude Medical, Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 361
- Deaths reported
- 5
- Injuries reported
- 202
- Recalls
- 0
We found 3 models of Victory by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 361 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2018 and Aug 27, 2026 — classified as 5 deaths, 202 injuries, 154 malfunctions.
The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (77 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Victory problems
Device problems
- Pacemaker Found in Back-Up Mode77
- Adverse Event Without Identified Device or Use Problem65
- Premature Discharge of Battery56
- Failure to Interrogate32
- No Pacing29
- Failure to Disconnect17
- Misconnection17
- Data Problem14
Patient problems
- No Known Impact Or Consequence To Patient155
- No Clinical Signs, Symptoms or Conditions103
- Unspecified Infection52
- Pocket Erosion14
- No Consequences Or Impact To Patient10
- Arrhythmia9
- Death5
- Discomfort5
Victory models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Victory™ 5816implantable pacemaker Pulse-generator5 deaths347 reports
- Victory® SRProgrammer, pacemaker8 reports
- Victory® 5810implantable pacemaker Pulse-generator6 reports
Recent Victory adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Unexpected Mode Switch
It was reported that the patient presented for a follow-up in clinic. Interrogation revealed that the pacemaker had entered backup VVI mode. The patient was then admitted to the hospital and attempts to restore the pacemaker to normal operation through reprogramming were unsuccessful due to normal battery depletion. No intervention or changes were performed. No patient consequences were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50465139 ↗MalfunctionJan 7, 2026Unexpected Mode Switch
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW UP CHECK-UP AT THE HOSPITAL. IT WAS NOTED THAT THE PACEMAKER ENTERED BACKUP MODE DUE TO PATIENT 'S LONG-TERM USE OF MAGNETIC THERAPY APPARATUS. PROGRAMMING CHANGES WERE MADE, AND THE PACEMAKER WAS RESTORED TO NORMAL MODE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23987201 ↗InjuryNov 18, 2025Unexpected Mode Switch; Unexpected Mode Switch
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT. IT WAS DISCOVERED THAT THE PATIENT'S PACEMAKER WAS IN BACKUP VVI MODE WHILE IN ELECTIVE REPLACEMENT INDICATOR (ERI). THE PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584917 ↗InjuryOct 31, 2025Unexpected Mode Switch; Unexpected Mode Switch
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC. UPON INTERROGATION, THE PACEMAKER WAS FOUND TO BE IN BACKUP VVI MODE. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT'S STATUS WAS UNKNOWN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436092 ↗InjuryJun 9, 2025High impedance; No Pacing; High impedance; No Pacing
IT WAS REPORTED THAT THE PATIENT SUDDENLY FAINTED. A SUBSEQUENT INTERROGATION OF THE PACEMAKER SHOWED AN INDIRECT LOSS OF CAPTURE. RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN THE UPPER LIMIT. THE PHYSICIAN ELECTED TO REPLACE THE LEADS AND PACEMAKER. FRACTURE OF THE RV LEAD WAS NOTED. THE LEADS WERE CAPPED, AND THE DEVICE WAS SUCCESSFUL EXPLANT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Syncope/Fainting
MAUDE report 22168887 ↗MalfunctionApr 28, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING EPISODES DUE TO POST-PACED T-WAVE OVERSENSING ON THE PACEMAKER (PM). PROGRAMMING CHANGES WERE MADE TO RESOLVE THE ISSUE. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21922297 ↗InjuryJan 21, 2025Premature Discharge of Battery; Capturing Problem; Inappropriate or Unexpected Reset; Unexpected Mode Switch; Premature Discharge of Battery; Capturing Problem; Inappropriate or Unexpected Reset; Unexpected Mode Switch
IT WAS REPORTED PATIENT'S PACEMAKER INAPPROPRIATELY WENT INTO BACKUP MODE. THE DEVICE EXHIBITED HIGH OUTPUT VOLTAGE RATES WHICH CAUSED PREMATURE BATTERY DEPLETION. THE PACEMAKER WAS EXPLANTED AND REPLACED SUCCESSFULLY. PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21199989 ↗MalfunctionJan 16, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR AN UNRELATED PROCEDURE. DURING THE PROCEDURE IT WAS NOTED THAT THE PACEMAKER FAILED TO CONNECT TO THE RIGHT-VENTRICULAR (RV) LEAD. AS A RESOLUTION THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21175360 ↗MalfunctionOct 13, 2024Failure to Interrogate; No Pacing; Failure to Interrogate; No Pacing
IT WAS REPORTED DURING DEVICE CHANGEOUT THAT THE PACEMAKER FAILED TO BE INTERROGATED AND DISPLAYED NO LOW VOLTAGE PACING. THE DEVICE WAS SUCCESSFULLY EXCHANGED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20436523 ↗InjuryJul 2, 2024Unexpected Mode Switch; Unexpected Mode Switch
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IN CLINIC FOLLOW-UP WITH THE PULSE GENERATOR IN BACKUP OPERATION DUE TO BATTERY EXHAUSTION. UPON FURTHER ASSESSMENT IT WAS NOTED THAT HIGH CAPTURE THRESHOLD WAS EXHIBITED BY THE RIGHT VENTRICULAR LEAD, WHICH CAUSED THE GENERATOR TO OPERATE AT HIGH OUTPUT. THE PHYSICIAN ATTRIBUTED THE HIGH CAPTURE THRESHOLD TO PATIENT ANATOMY. THE PATIENT WAS SCHEDULED FOR REPLACEMENT ON (B)(6) 2024. THE LEAD WAS CAPPED, AND THE GENERATOR WAS EXPLANTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19656825 ↗InjuryJun 26, 2024No Pacing; No Pacing
DURING A ROUTINE DEVICE EXCHANGE PROCEDURE, THE DEVICE LOST PACING DUE TO ELECTROCAUTERY AND THE PATIENT ENTERED ASYSTOLE. THE LEADS WERE QUICKLY DETACHED FROM THE DEVICE AND CONNECTED TO AN EXTERNAL PACEMAKER TO RESOLVE THE ARRHYTHMIA. A REPLACEMENT DEVICE WAS THEN IMPLANTED WITHOUT FURTHER COMPLICATION. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Arrhythmia
MAUDE report 19615986 ↗InjuryJun 24, 2024Unexpected Mode Switch; Unexpected Mode Switch
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH THE PACEMAKER IN BACKUP VVI MODE. THE PHYSICIAN TRIED TO RESTORE THE PACEMAKER BUT IT WAS UNSUCCESSFUL. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19594109 ↗MalfunctionMar 1, 2024Failure to Disconnect; Failure to Disconnect
DURING A DEVICE REPLACEMENT PROCEDURE FOR NORMAL END OF LIFE (EOL), THE VENTRICULAR LEAD WAS UNABLE TO BE DISCONNECTED FROM THE DEVICE. THE VENTRICULAR LEAD WAS DISCONNECTED FROM THE DEVICE BY DAMAGING THE DEVICE HEADER DURING THE PROCEDURE. THE DEVICE WAS THEN REPLACED AS ANTICIPATED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18817861 ↗InjuryJan 31, 2024Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THE PATIENT'S PULSE GENERATOR HAD FAILED TO BE INTERROGATED. THE PULSE GENERATOR WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18612773 ↗InjuryJan 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC WITH THE SKIN OF THE DEVICE POCKET APPEARING SWOLLEN AND INFECTION AT THE IMPLANTED DEVICE POCKET SITE. ALSO, IT WAS NOTED THAT THE PACEMAKER HAS ERODED FROM THE POCKET. THE PHYSICIAN EXPLANTED AND REPLACED THE PACEMAKER. BOTH RIGHT VENTRICULAR LEAD AND ATRIAL LEAD WERE CAPPED AND REPLACED ON (B)(6) 2023. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 18423199 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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