Victory™ 5816Recalls & reported problems

Summary

The FDA's MAUDE database contains 347 adverse event reports that list this exact device (DI 05414734009553), received between Jun 13, 2018 and Aug 27, 2026 — classified as 5 deaths, 193 injuries, 149 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (69 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 25 most recent of 347 reports, 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 ↗
• 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 ↗
• MalfunctionDec 18, 2023Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR GENERATOR CHANGEOUT PROCEDURE. DURING PROCEDURE, IT WAS FOUND THAT THE PACEMAKER SET SCREW WAS UNABLE TO BE LOOSENED. THE CORRESPONDING LEAD WAS CUT AND CAPPED DURING THE PROCEDURE ON (B)(6) 2023, SO THAT THE PACEMAKER COULD BE EXPLANTED AND REPLACED. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352520 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW INFORMATION NOTED THAT THE PATIENT HAD THEIR ENTIRE PACEMAKER SYSTEM EXPLANTED DUE TO INFECTION AND POCKET EROSION.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 18352329 ↗
• InjuryNov 16, 2023Failure to Interrogate; Pacemaker Found in Back-Up Mode; Defective Device; Failure to Interrogate; Pacemaker Found in Back-Up Mode; Defective Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A SCHEDULED FOLLOW UP. UPON REVIEW, THE PACEMAKER WAS FOUND IN BACKUP VVI MODE. THE DEVICE COULD NOT BE INTERROGATED. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT'S CONDITION WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149696 ↗
• InjuryNov 1, 2023Failure to Disconnect; Failure to Disconnect

  DURING A NORMAL DEVICE REPLACEMENT PROCEDURE, THE VENTRICULAR LEAD WAS UNABLE TO BE REMOVED FROM THE DEVICE HEADER. MULTIPLE ATTEMPTS WERE MADE BUT UNSUCCESSFUL. DUE TO PATIENT ANATOMY, THE DEVICE WAS UNABLE TO BE EXCHANGED DURING THE PROCEDURE. AN ADDITIONALLY PROCEDURE OCCURRED, AND AGAIN, THE VENTRICULAR LEAD WAS UNABLE TO BE REMOVED FROM THE HEADER. THE LEAD WAS CUT AND REPLACED AND A NEW DEVICE WAS ABLE TO BE IMPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18047622 ↗
• MalfunctionOct 13, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A SCHEDULED FOLLOW UP. UPON INTERROGATION OF THE PATIENT¿S PACEMAKER, THE DEVICE WAS FOUND IN BACKUP VVI MODE DUE TO ELECTROMAGNETIC FIELD INTERFERENCES (EMI). THE DEVICE HAS REVERTED TO ITS NORMAL SETTINGS BY REPROGRAMMING. THE PATIENT HAD NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936446 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH A POCKET INFECTION. THE PHYSICIAN ELECTED TO EXPLANT THE PACEMAKER (PM) SYSTEM. THE PATIENT CONDITION WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 17928993 ↗
• MalfunctionOct 10, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED, THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) SOONER THEN THE ESTIMATED LONGEVITY AT THE PREVIOUS FOLLOW UP. LONGEVITY OVERESTIMATION DUE TO THE DEVICE WAS SUSPECTED. THE DEVICE WAS EXCHANGED DUE TO NORMAL ERI. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905575 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT PRESENTED WITH AN INFECTION AND EROSION. THEIR SYSTEM WAS EXPLANTED IN A PROCEDURE ON (B)(6) 2023. POST-PROCEDURE THE PATIENT WAS STABLE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 17837318 ↗
• MalfunctionSep 25, 2023Failure to Disconnect; Failure to Disconnect

  DURING A REPLACEMENT PROCEDURE, IT WAS NOT POSSIBLE TO UNSCREW THE SET SCREW TO RELEASE THE LEAD. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17811710 ↗
• MalfunctionAug 31, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  DURING AN IN CLINIC FOLLOW UP, THE DEVICE WAS FOUND TO BE BACK UP MODE. TECHNICAL SUPPORT WAS CONTACTED AND IT WAS SUSPECTED THE BACK UP MODE WAS DUE TO THE DEVICE BEING AT ELECTIVE REPLACEMENT INDICATOR (ERI). A DEVICE EXCHANGE IS ANTICIPATED BUT HAS NOT YET BEEN PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666234 ↗
• MalfunctionAug 30, 2023Loose or Intermittent Connection; No Pacing; Loose or Intermittent Connection; No Pacing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PULSE GENERATOR'S SET SCREW WAS NOT ABLE TO BE TIGHTENED AND NO PACING OUTPUT WAS NOTED. THE PULSE GENERATOR WAS NOT USED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17655945 ↗

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-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• Z-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• 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-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-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