Victory® SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05414734009539), received between Jul 30, 2018 and Apr 28, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (6 reports).

9 other recalls cover devices cleared under the same FDA submission (P880086); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionNov 6, 2020Premature Discharge of Battery; Premature Discharge of Battery

  ADDITIONAL INFORMATION INDICATED THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10804656 ↗
• InjuryNov 5, 2020Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10793053 ↗
• InjuryOct 5, 2020Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO A FOLLOW-UP IN-CLINIC WITH THEIR PACEMAKER EXHIBITING BACKUP VVI MODE. IT WAS SUSPECTED TO BE CAUSED BY THE DEVICE REACHING END OF LIFE. DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2020. PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10632457 ↗
• InjuryNov 1, 2019Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WENT INTO BACKUP VVI MODE. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9267631 ↗
• MalfunctionNov 20, 2018Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF CHEST PAIN. UPON INTERROGATION, IT WAS DISCOVERED THE PACEMAKER WAS IN BACKUP VVI OPERATION. PROGRAMMING CHANGES COULD NOT BE MADE, AS THE BATTERY HAD REACHED ITS ELECTIVE REPLACEMENT INDICATOR NORMALLY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Chest Pain

  MAUDE report 8091119 ↗
• InjurySep 6, 2018Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  DURING A CLINIC FOLLOW UP, IT WAS NOTED THAT THE DEVICE WENT INTO BACK UP MODE. THE DEVICE WAS EXPLANTED AND EXCHANGED TO RESOLVE THE EVENT AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852122 ↗
• MalfunctionJul 30, 2018Intermittent Capture; Pacemaker Found in Back-Up Mode; Intermittent Capture; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE GENERATOR CHANGE PROCEDURE. DURING EXPOSURE TO ELECTROCAUTERY, THE PULSE GENERATOR REVERTED TO BACKUP OPERATION. INTERMITTENT LOSS OF CAPTURE WAS NOTED DUE TO THE CHANGE TO UNIPOLAR PACING. FURTHER INTERROGATION WAS NOT POSSIBLE DUE TO THE DEVICE'S BACKUP OPERATION. THE DEVICE WAS REMOVED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7733367 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P880086. One submission often covers many models, so check the product and lot details in each record.

• Z-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• Z-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• Z-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• Z-0430-2012 · Sep 23, 2011 · Terminated
  Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0429-2012 · Sep 23, 2011 · Terminated
  Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0298-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
• Z-0296-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510
• Z-0297-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
• Z-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator