Victory® 5810Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734009546), received between Jul 19, 2018 and May 14, 2019 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Interrogate” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2019Premature Discharge of Battery; High impedance; Premature Discharge of Battery; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH HIGH IMPEDANCE ON THE PACEMAKER. IT WAS ALSO NOTED THAT THE BATTERY PREMATURELY DEPLETED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8607963 ↗
• InjuryMay 1, 2019Failure to Interrogate; Battery Problem; Failure to Interrogate; Battery Problem

  DURING FOLLOW-UP, THE PHYSICIAN WAS UNABLE TO INTERROGATE THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED BUT PREMATURE BATTERY DEPLETION COULD NOT BE CONFIRMED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8569477 ↗
• MalfunctionApr 4, 2019Difficult to Interrogate; Pacemaker Found in Back-Up Mode; Difficult to Interrogate; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE DEVICE EXHIBITED BACKUP VVI OPERATION MOST PROBABLY DUE TO LOW BATTERY. DUE TO POOR TELEMETRY THE DEVICE WAS NOT RESTORED FROM BACKUP TO NORMAL FUNCTIONS. THE PATIENT EXPERIENCED POCKET STIMULATION AND DISCOMFORT. NO INTERVENTION WAS PERFORMED. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Discomfort; Muscle Stimulation

  MAUDE report 8485568 ↗
• InjuryMar 15, 2019Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED BACKUP VVI MODE. UPON INTERROGATION, THE DEVICE EXHIBITED ELECTIVE REPLACEMENT INDICATOR ¿ ERI. IT WAS NOTED THE PATIENT WAS LOST TO FOLLOW-UP. NO INTERVENTION WAS REPORTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8423559 ↗
• InjuryDec 17, 2018Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  NEW INFORMATION RECEIVED NOTED THE PATIENT PRESENTED FOR A PACEMAKER EXPLANT AND REPLACEMENT PROCEDURE. THE DAY OF THE PROCEDURE, THE DEVICE WAS UNABLE TO BE INTERROGATED. COMPLETE BATTERY DEPLETION WAS SUSPECTED. THE PATIENT EXPERIENCED BRADYCARDIA AND REPORTED FEELING FATIGUED FOR THE WEEKS PRIOR. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2019. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: Bradycardia; Fatigue

  MAUDE report 8171735 ↗
• InjuryJul 19, 2018Data Problem; Data Problem

  DURING A FOLLOW-UP IN CLINIC, THE DEVICE WAS INTERROGATED AND AN ESTIMATION OF REMAINING LONGEVITY COULD NOT BE OBTAINED. A MESSAGE WAS THEN DELIVERED INDICATING THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS EXPLANTED AND REPLACED AND THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7703791 ↗

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-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• Z-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 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-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-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-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator