Sensia™ SEDR01 (UDI 00613994222138)Recalls & reported problems

Summary

The FDA's MAUDE database contains 434 adverse event reports that list this exact device (DI 00613994222138), received between Dec 9, 2016 and Aug 31, 2026 — classified as 10 deaths, 261 injuries, 163 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (81 reports).

16 other recalls cover devices cleared under the same FDA submission (P980035); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 434 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519964 ↗
• MalfunctionApr 23, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT AN IMPLANTABLE PULSE GENERATOR IMPLANTED IN (B)(6) 2014 WAS APPROACHING THE ELECTIVE REPLACEMENT INDICATOR, AND THERE WAS AN INCREASE IN CURRENT DRAIN WITH INCREASED OUTPUT AND INCREASED PULSE WIDTH, RAISING CONCERN FOR REDUCED BATTERY LONGEVITY AND INCREASED BATTERY COST. IT WAS ALSO REPORTED THAT THERE WAS CONCERN REGARDING THE RIGHT VENTRICULAR LEAD, AND THOROUGH TESTING WITH A FULL LEAD EVALUATION WAS DISCUSSED AND RECOMMENDED, ALTHOUGH IMPEDANCE WAS NOT REPORTED TO BE TRENDING OUT OF RANGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24964603 ↗
• MalfunctionApr 8, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA WHEN THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE IPG WAS PACING BELOW THE LOWER RATE. THE IPG WAS REMOVED AND REPLACED AS IT HAD REACHED NORMAL ERI. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 24814900 ↗
• MalfunctionOct 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THERE WERE NO PERFORMANCE ISSUE WITH THE IPG. THE DEVICE REACHED END OF SERVICE HENCE WAS UNABLE TO INTERROGATE AND THE BATTERY LOSS WAS NOT PREMATURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355340 ↗
• MalfunctionOct 16, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A READER POSITION ISSUE OCCURRED WITH THE MONITOR, RESULTING IN NO TELEMETRY AND NO PROGRESS BAR BEING DISPLAYED. THE POSITION OF THE READER WAS ADJUSTED, THE MONITOR WAS POWER CYCLED, A DRY WASHCLOTH WAS TRIED, AND IT WAS CONFIRMED THAT NO MAJOR ELECTRONICS WERE NEARBY. DESPITE THESE TROUBLESHOOTING STEPS, THE ISSUE REMAINED UNRESOLVED AND THE PATIENT WAS REFERRED TO A CLINIC. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308580 ↗
• InjuryAug 12, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE IPG WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22789818 ↗
• InjuryJul 25, 2025Premature Discharge of Battery; Communication or Transmission Problem; Reset Problem; Premature Discharge of Battery; Communication or Transmission Problem; Reset Problem

  IT WAS FURTHER REPORTED THAT THE IPG WAS EXPLANTED DUE TO BATTERY DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22606678 ↗
• MalfunctionJul 7, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS A READER POSITION ISSUE WITH THE MYCARELINK MONITOR. THE READER WAS NOT READING THE PACEMAKER, THE PR OGRESS BAR DID NOT FILL DURING ATTEMPTED TRANSMISSION, AND THE READER WAS SHOWING A BLUE LIGHT WHEN PLACED ON THE PATIENT¿S CHEST, INDICATING A MALFUNCTION OR IRREGULARITY. IT WAS SUGGESTED THAT THE PATIENT MAY NEED TO HAVE THEIR DEVICE INTERROGATED IN OFFICE. THE READER POSITION WAS ADJUSTED, AND INTERFERENCE WAS REMOVED. ADDITIONAL TROUBLESHOOTING INCLUDED PLACING A DRY WASH CLOTH AND FURTHER REMOVING INTERFERENCE, BUT THE ISSUE PERSISTED. THE PATIENT WAS ADVISED TO MAKE AN APPOINTMENT, BRING THE MONITOR, AND MAY NEED TO HAVE THEIR DEVICE INTERROGATED IN OFFICE. IT WAS ALSO THERE WAS NO TELEMETRY WITH THE IPG. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412860 ↗
• InjuryJun 13, 2025Reset Problem; Reset Problem

  IT WAS FURTHER REPORTED THAT THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Lethargy; Syncope/Fainting

  MAUDE report 22201774 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET INFECTION. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED FEVER AND REDNESS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Fever; Medical device site infection

  MAUDE report 22035217 ↗
• MalfunctionApr 24, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING A GENERATOR CHANGE OUT PROCEDURE, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PROGRAMMED TO ASYNCHRONOUS P ACING AND SHOWED INHIBITION DURING CAUTERY. THE IPG WAS PROPHYLACTICALLY EXPLANTED AND REPLACED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898018 ↗
• InjuryApr 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS NOTED THAT THE IPG WAS REMOVED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI) AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855326 ↗
• InjuryApr 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS FURTHER REPORTED THAT THE IPG HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND WAS ELECTIVELY REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855030 ↗
• InjuryApr 4, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THERE WAS INTERMITTENT NON CAPTURE WITH PERIODS OF ASYSTOLE OBSERVED ON THE TELEMETRY MONITOR. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole

  MAUDE report 21773047 ↗
• MalfunctionMar 6, 2025Failure to Interrogate; Pacing Problem; Failure to Interrogate; Pacing Problem

  IT WAS REPORTED THAT THE PATIENTS DEVICE WAS NOT SUCCESSFULLY INTERROGATED. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO PACING DUE TO PATIENT BEING BRADYCARDIC. THE IPG WAS EXPLANTED AND REPLACED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21535593 ↗
• InjuryFeb 6, 2025Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT RIGHT VENTRICULAR CAPTURE MANAGEMENT UNEXPECTEDLY WENT TO HIGHER PACING OUTPUTS. THIS RESULTED ELECTIVE REPLACEMENT INDICATOR (ERI) SOON AFTER. THE IPG WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320834 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BACTERIAL ENDOCARDITIS INFECTION AND BACTEREMIA. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Endocarditis

  MAUDE report 21157763 ↗
• MalfunctionDec 11, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND THE HEART RATE WAS NOTED TO BE AT FORTIES BEATS PER MINUTE AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING. THE DEVICE WAS PACING BELOW THE PROGRAMMED LOWER RATE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness

  MAUDE report 20900815 ↗
• InjuryNov 8, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED RAPID BATTERY DEPLETION AS CAPTURE MANAGEMENT UNEXPECTEDLY INCREASES THE PACING OUTPUTS. THE IPG STILL REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20639265 ↗
• InjuryNov 6, 2024Battery Problem; Reset Problem; Battery Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FULL POWER ON RESET (POR). IT WAS NOTED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND REPLACEMENT WAS RECOMMENDED SIX MONTHS PRIOR TO THE POR. IT WAS NOTED THAT THE PATIENT DEVELOPED COMPLETE HEART LOCK AND REQUIRED EXTERNAL PACING. THE DEVICE WAS LATER EXPLANTED AND REPLACED WITH A HIGHER POWER DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Block; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20618829 ↗
• InjuryOct 21, 2024Missing Test Results; Missing Test Results

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED INVALID BATTERY AND LEAD MEASUREMENT AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20492087 ↗
• MalfunctionOct 16, 2024Failure to Interrogate; Pacing Problem; Failure to Interrogate; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED THEIR HEART RATE AT THIRTIES BEATS PER MINUTE AND EXPERIENCED BIGEMINAL PREMATURE VENTR ICULAR CONTRACTIONS (PVC). THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW PROGRAMMED LOWER RATE. THE DEVICE WAS UNABLE TO BE INTERROGATED AND NO SUCCESSFUL TRANSMISSION COULD BE OBTAINED WITH TELEMETRY. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 20460505 ↗
• MalfunctionOct 15, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PALPITATIONS AND BRADYCARDIA. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERA TOR (IPG) WAS PACING BELOW THE LOWER RATE. THE IPG SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Bradycardia

  MAUDE report 20449232 ↗
• MalfunctionOct 3, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT'S REPRESENTATIVE THAT THE PATIENT'S HEART RATE WAS LOWER THAN NORMAL PACING. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20357242 ↗
• InjurySep 24, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT VENTRICULAR CAPTURE MANAGEMENT WENT TO HIGH PACING OUTPUTS WHICH RESULTED IN PREMATURE BATTERY DEPLETION OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20289336 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P980035. One submission often covers many models, so check the product and lot details in each record.

• Z-2128-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model N
• Z-2127-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D
• Z-1924-2025 · Apr 29, 2025 · Open, Classified
  Azure S DR MRI SureScan, Product number W3DR01
• Z-2509-2020 · Jun 4, 2020 · Open, Classified
  Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
• Z-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• Z-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• Z-2508-2020 · Jun 4, 2020 · Open, Classified
  Azure S DR MRI, Model Number W3DR01
• Z-0809-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
• Z-0806-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (
• Z-0807-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Numb
• Z-0808-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
• Z-0810-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
• Z-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• Z-2120-2011 · Apr 4, 2011 · Terminated
  Medtronic, Kappa 600 KDR600,KDR601,KDR603,KDR606,KDR651,KDR653 The devices are implantable pulse generators (IPG) used to detect bradycardia events and provide pacing support. Wit
• Z-1440-2010 · Feb 11, 2010 · Terminated
  Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects,

…and 1 more.