PromoteRecalls & reported problems across all models

We found 5 models of Promote by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 72 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Mar 5, 2024 — classified as 4 deaths, 42 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (27 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 Promote problems

Promote models

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

• Promote™ CD3211-36Q

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 deaths42 reports
• Promote™ CD3211-36

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  20 reports
• Promote® RF

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death5 reports
• Promote® 3107-36

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 reports
• Promote® RF

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 report

Recent Promote adverse event reports

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

• MalfunctionMar 5, 2024Signal Artifact/Noise; Pacing Problem; Signal Artifact/Noise; Pacing Problem

  IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE DEVICE. THE NOISE LED TO OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD. INAPPROPRIATE AUTOMATIC MODE SWITCH WAS ALSO OBSERVED. THE CAUSE OF THE NOISE WAS SUSPECTED TO BE DUE TO ELECTROMAGNETIC INTERFERENCE. LEAD DAMAGE ON THE RV LEAD AND RA LEAD WAS ALSO SUSPECTED BUT NOT CONFIRMED VISUALLY. NO INTERVENTION WAS PERFORMED; THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2024-34130, 2017865-2024-34132.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837765 ↗
• InjuryApr 27, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED VIA INDUCTIVE TELEMETRY DURING AN IN CLINIC FOLLOW-UP. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16822839 ↗
• MalfunctionMar 1, 2023Defective Device; Defective Device

  DURING A ROUTINE DEVICE EXCHANGE, THE DEVICE WAS EXPLANTED AND A PORTION OF THE HEADER DETACHED ON THE TABLE. THE NEW DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16463522 ↗
• MalfunctionFeb 13, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, THE DEVICE WAS FOUND TO HAVE REACHED END OF LIFE (EOL) BATTERY VOLTAGE. AT THE PREVIOUS INTERROGATION, APPROXIMATELY 14 MONTHS PRIOR, THE LONGEVITY ESTIMATION ON THE BATTERY WAS MORE THAN 2 YEARS TO ELECTIVE REPLACEMENT INDICATOR (ERI) LEVEL. THE PHYSICIAN SUSPECTED THE BATTERY DEPLETION WAS NORMAL AND LONGEVITY OVERESTIMATION OCCURRED AT THE PREVIOUS FOLLOW UP. THE DEVICE WAS EXPLANTED DUE TO NORMAL ERI/EOL AND WAS REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368513 ↗
• InjuryNov 11, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT A DECREASE IN THE BATTERY LONGEVITY WAS OBSERVED AND PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15777712 ↗
• InjuryJun 20, 2022Naturally Worn; Naturally Worn

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-12904. IT WAS REPORTED THAT DURING ROUTINE GENERATOR EXCHANGE THAT DEVICE INTERROGATION REVEALED CAUSED BY EXTERNALIZED CONDUCTORS DAMAGE VISUALLY FOUND ON THE RIGHT VENTRICULAR (RV). ON FURTHER INTERROGATION IT SHOWED HIGH CAPTURE THRESHOLDS ON THE LEFT VENTRICLE (LV) LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RV AND LV LEAD. THE PATIENT WAS IN STABLE CONDITION BEFORE, DURING, AND AFTERWARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14744059 ↗
• MalfunctionMay 6, 2022Incorrect Measurement; Incorrect Measurement

  DURING A CLINIC FOLLOW-UP, A DECREASE IN THE BATTERY LONGEVITY WAS NOTED ON THE DEVICE AND IT WAS SUSPECTED THAT THERE WAS AN OVERESTIMATION OF THE DEVICE LONGEVITY AT A PREVIOUS FOLLOW-UP. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS EXPLANTED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI) AND REPLACED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310572 ↗
• InjuryDec 6, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT A DROP IN ESTIMATED BATTERY LONGEVITY WAS NOTED ON THE DEVICE. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933473 ↗
• InjurySep 20, 2021Failure to Charge; Failure to Charge

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12501639 ↗
• InjuryAug 17, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  BACKUP OPERATION WAS REPORTED ON THE DEVICE. THE DEVICE WAS EXPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332780 ↗
• MalfunctionAug 13, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT AN INACCURATE DROP IN BATTERY VOLTAGE WAS OBSERVED ON THE DEVICE DURING FOLLOW-UP. ABBOTT TECHNICAL SUPPORT WAS CONTACTED BUT THE CAUSE OF THE DROP IN BATTERY VOLTAGE COULD NOT BE DETERMINED. NO INTERVENTION WAS PERFORMED; THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12320957 ↗
• InjuryApr 6, 2021Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  DURING A FOLLOW-UP, THE DEVICE COULD NOT BE INTERROGATED DUE TO BEING AT END OF LIFE (EOL). PREMATURE BATTERY DEPLETION WAS ALLEGED. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624570 ↗
• InjuryMar 8, 2021Battery Problem; Battery Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441070 ↗
• InjuryDec 8, 2020Premature Discharge of Battery; Premature Discharge of Battery

  A DECREASE IN THE DEVICE BATTERY LONGEVITY WAS REPORTED AND POSSIBLE PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10970189 ↗
• MalfunctionDec 4, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE PATIENT PRESENTED IN CLINIC AFTER RECEIVING INAPPROPRIATE DEFIBRILLATION THERAPY FOR SUPRAVENTRICULAR TACHYCARDIA. THE PHYSICIAN DID NOT ALLEGE A MALFUNCTION AGAINST THE DEVICE AND STATED THE DEVICE PERFORMED AS EXPECTED BASED UPON ITS PROGRAMMED SETTINGS. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 10945235 ↗

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