AccentRecalls & reported problems across all models

We found 4 models of Accent by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,836 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 10, 2026 — classified as 113 deaths, 652 injuries, 1,071 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (285 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

Most reported Accent problems

Accent models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Accent® DR RF

  Pulse generator, permanent, implantable
  73 deaths1,370 reports
• Accent™ DR

  Pulse generator, permanent, implantable
  20 deaths214 reports
• Accent™ SR RF

  Pulse generator, permanent, implantable
  12 deaths164 reports
• Accent™ SR

  Pulse generator, permanent, implantable
  8 deaths88 reports

Recent Accent adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Low impedance

  It was reported that the patient presented to the clinic for follow-up. Low pacing impedance measurements were observed while the pacemaker (PM) was at the normal elective replacement indicator (ERI) stage. Consequently, the PM was explanted and replaced with a new PM on (b)(6)2026. The existing atrial and right ventricle (RV) leads were retained and successfully reconnected to the newly implanted PM. Subsequent Pacing System Analyzer (PSA) testing and lead impedance measurements performed after reconnection to the replacement PM were within normal limits, indicating acceptable lead impedance measurements with both the explanted and replacement PMs. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50706609 ↗
• InjuryJul 3, 2026Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. REMOTE CARE TECHNICAL SERVICES WAS CONTACTED TO ASSIST WITH A MERLIN ON DEMAND (MOD) TRANSMISSION. THE MOD TRANSMISSION WAS SENT SUCCESSFULLY BUT IT WAS NOTED THAT THE PACEMAKER EXHIBITED TELEMETRY LOCKOUT. THE PACEMAKER WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THE PATIENT REMAINED STABLE BEFORE, DURING AND AFTER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25701961 ↗
• InjuryJun 30, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCE CHEST PAIN. IT WAS NOTED THAT THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS NOT KNOWN.

  Patient problems: Discomfort

  MAUDE report 25673792 ↗
• InjuryJun 9, 2026Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGES PROCEDURE. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER, RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW PACING IMPEDANCE. THE PACEMAKER WAS EXPLANTED. THE RA AND RV LEADS WAS STILL IMPLANTED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25452124 ↗
• MalfunctionJun 2, 2026Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER WAS BEEPING EVERY FEW SECONDS WITHOUT STOPPING. NO INTERVENTIONS OR CHANGES WERE PERFORMED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368772 ↗
• MalfunctionMay 24, 2026Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER HAD ENTERED BACK-UP VVI MODE. THE PACEMAKER WAS RESTORED. THE PATIENT HAD NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267304 ↗
• MalfunctionMay 20, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER EXHIBITED NOISE EPISODES. THE INTERVENTION AND PATIENT CONDITION WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25229281 ↗
• MalfunctionApr 27, 2026Signal Artifact/Noise; Over-Sensing

  NEW INFORMATION RECEIVED NOTES THAT THE PACEMAKER EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN PACING INHIBITION. THE NOISE ISSUE WAS OBSERVED YEARS AGO, AND THE CLINIC WAS MONITORING THE PACEMAKER. NO INTERVENTIONS OR CHANGES WERE PERFORMED, AND THE PACEMAKER WILL CONTINUE TO BE MONITORED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010183 ↗
• MalfunctionApr 23, 2026Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. DURING THE FOLLOW-UP, THE PATIENT'S PACEMAKER WENT INTO BACKUP VVI MODE DURING A CYBERSECURITY UPDATE. THE DEVICE WAS SUCCESSFULLY RESTORED TO NOMINAL SETTINGS, AND THE PATIENT DID NOT EXPERIENCE ANY CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971190 ↗
• MalfunctionMar 30, 2026Failure to Interrogate; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER COULD NOT BE INTERROGATED. NO INTERVENTION WAS REPORTED. THE PATIENT STATUS WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24718104 ↗
• MalfunctionMar 10, 2026Inappropriate or Unexpected Reset; Unexpected Mode Switch

  IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS NOTED THAT PACEMAKER WAS IN BACK-UP MODE AND THE DEVICE STATUS REPORT DISPLAYED DASHES, WITH BATTERY VOLTAGE AND ESTIMATED LONGEVITY UNAVAILABLE. THE CLINIC ATTEMPTED A BACKUP RESTORATION, BUT THE DOWNLOAD FAILED, LIKELY DUE TO LOW BATTERY STATUS. NO OTHER INTERVENTION WAS REPORTED. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561375 ↗
• InjuryFeb 4, 2026Failure to Capture; Failure to Sense

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A METAL ALLERGY AND THEIR PACEMAKER EXHIBITED A FAILURE TO PACE AND SENSE. THE PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT'S STATUS WAS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24260780 ↗
• MalfunctionDec 11, 2025Loose or Intermittent Connection; Failure to Disconnect; Contamination of Device Ingredient or Reagent; Loose or Intermittent Connection; Failure to Disconnect; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE GENERATOR CHANGE OUT PROCEDURE. DURING THE PROCEDURE, THE PACEMAKER'S ATRIAL SET SCREW COULD NOT BE ENGAGED WITH THE WRENCH. SOME SORT OF HARD BUILD UP WAS NOTED ON THE SET SCREW SLOT. THE ATRIAL LEAD COULD NOT BE SEPARATED SO IT WAS CUT AND CAPPED. THE DEVICE AND LEAD WERE THEN SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779738 ↗
• InjuryNov 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SYMPTOMATIC DUE TO PACEMAKER'S AUTO CAPTURE FEATURE. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23677423 ↗
• MalfunctionNov 28, 2025Loose or Intermittent Connection; Failure to Disconnect; Loose or Intermittent Connection; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SET SCREW OF THE PACEMAKER WAS STRIPPED AND RIGHT VENTRICULAR (RV) LEAD COULD NOT BE REMOVED FROM THE PACEMAKER HEADER. THE PHYSICIAN USED ORTHOPEDIC BONE CRUSHER TOOL TO CRUSH THE PACEMAKER AND REMOVED THE RV LEAD. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669337 ↗

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