Sensia™ SESR01 (UDI 00613994223807)Recalls & reported problems

Summary

The FDA's MAUDE database contains 315 adverse event reports that list this exact device (DI 00613994223807), received between Dec 9, 2016 and Jun 30, 2026 — classified as 5 deaths, 194 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (95 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 315 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE MYCARELINK REMOTE MONITOR WAS UNABLE TO DETECT THE IMPLANTABLE PULSE GENERATOR (IPG) AND CONTINUOUSLY SEARCHED FOR A CONNECTION. THE CALLER STATED THAT NO PROGRESS BAR APPEARED ON THE SCREEN DESPITE MULTIPLE ATTEMPTS. VERIFIED THE DEVICE STATUS AND GUIDED THE CALLER THROUGH TROUBLESHOOTING STEPS, INCLUDING CHECKING SIGNAL STRENGTH, ENSURING THE READER WAS PROPERLY POSITIONED ON THE PATIENT¿S CHEST, AND TO UNPLUG AND RECONNECT THE MONITOR. THE ISSUE REMAINED UNRESOLVED AFTER TROUBLESHOOTING. THE CALLER WAS ADVISED TO SCHEDULE AN APPOINTMENT WITH THE PATIENT¿S PHYSICIAN FOR FURTHER EVALUATION. 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 25664001 ↗
• MalfunctionFeb 16, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT A READER POSITION ISSUE OCCURRED WITH THE MYCARELINK MONITOR FOR A PACEMAKER, RESULTING IN NO TELEMETRY. DURING TROUBLESHOOTING, A MANUAL TRANSMISSION PROCESS WAS INITIATED, BUT THE PROGRESS BAR BECAME STUCK AT ONE QUARTER AND DID NOT FILL AFTER FURTHER TROUBLESHOOTING STEPS, WHICH INCLUDED ADJUSTING THE READER, POWER CYCLING THE MONITOR, PLACING A DRY WASH CLOTH, AND REMOVING INTERFERENCE. THE PATIENT WAS REFERRED TO A CLINIC FOR FURTHER ASSISTANCE AND INSTRUCTED TO MAKE AN APPOINTMENT AND BRING THE MONITOR TO THE 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 24343880 ↗
• InjuryJan 20, 2026Premature Discharge of Battery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24113978 ↗
• MalfunctionJan 14, 2026Premature Discharge of Battery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066147 ↗
• MalfunctionNov 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RECHARGING OF THE PATIENT'S REPRESENTATIVE'S SPINAL CORD STIMULATOR INTERFERED WITH THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG). THE IPG WAS LATER EXPLANTED AND REPLACED FOR UNKNOWN REASONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23670422 ↗
• InjuryOct 23, 2025Pacing Problem; Failure to Power Up; Pacing Problem; Failure to Power Up

  IT WAS REPORTED THAT DURING GENERATOR CHANGE THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PACING FAILURE. THE DEVICE 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 23365172 ↗
• InjurySep 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED DISLODGEMENT. THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT CO MPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094061 ↗
• InjuryAug 13, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE DUE TO NO PACING FROM THE IMPLANTABLE PULSE GENERATOR (IPG). DEVICE AT END OF SERVICE (EOS) WAS SUSPECTED. EXTERNAL PACING SUPPORT WAS PROVIDED. LATER, THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791523 ↗
• MalfunctionJul 31, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT A PATIENT ATTEMPTED TO USE THEIR MYCARELINK MONITOR FOR A PACEMAKER AND THE MONITOR WAS NOT RESPONDING. THE PATIENT ALSO EXPERIENCED AN ISSUE WITH READER POSITION AND NO TELEMETRY WITH MYCARELINK. TROUBLESHOOTING STEPS WERE PERFORMED ACCORDING TO PRODUCT LABELING, INCLUDING EVALUATION USING MULTIPLE KNOWLEDGE BASES AND OBSERVING A WHITE CLOUD WITH AN ARROW POINTING DOWN ON THE MONITOR DISPLAY. AFTER UPDATING FOR ONE HOUR, FURTHER TROUBLESHOOTING WAS CONDUCTED, AND THE CASE WAS REFERRED TO A CLINIC. THE PATIENT WAS ADVISED TO MAKE AN APPOINTMENT, BRING THE MONITOR, AND MAY NEED TO HAVE THEIR DEVICE INTERROGATED IN THE OFFICE. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A TELEMETRY ISSUE. 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 22673688 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ENDOCARDITIS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND THE PATIENT WAS TREATED ANTIBIOTICS. A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 22628729 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE IPG SYSTEM RELATED TO THE PATIENT'S LEFT SIDED POCKET EROSION WAS NOT A MEDTRONIC SYSTEM.

  Patient problems: Pocket Erosion

  MAUDE report 22458162 ↗
• MalfunctionMay 30, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD NO TELEMETRY. 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 22112495 ↗
• InjuryFeb 21, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EPICARDIAL LEAD EXHIBITED INTERMITTENT NON-CAPTURE AND INCREASED PACING THRESHOLDS. IT WAS ALSO NOTED THAT THE IPG EXHIBITED PREMATURE DEPLETION. THE RV EPICARDIAL LEAD WAS CAPPED AND REPLACED AND 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 21432967 ↗
• InjuryNov 13, 2024Pacing Problem; Pacing Problem

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

  Patient problems: Arrhythmia; Bradycardia

  MAUDE report 20673467 ↗
• InjuryOct 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT WITH THEIR PREVIOUS IMPLANTABLE PULSE GENERATOR (IPG), WHEN WORKING IN FACTORIES, "I ACTUALLY FELT IT THAT IT WAS INTERFERING WITH THINGS" AND "I COULD FEEL IT IN MY CHEST.". THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407865 ↗
• MalfunctionOct 1, 2024Pacing Problem; Reset Problem; Pacing Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING AND THE PATIENT EXPERIENCED HEART RATE AT THIRTY ONE BEATS PER MINUTE.  ELECTRICAL RESET WAS NOTED AND WAS CONFIRMED DUE TO SEVERELY DEPLETED BATTERY. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 20342838 ↗
• MalfunctionSep 19, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) VENTRICULAR LEAD SENSITIVITY WAS NOT DISPLAYED ON THE DATA SUMMARY REPORT FROM THE MOBILE PROGRAMMER. IT WAS NOTED THAT THERE WAS AN AREA WHERE THE VENTRICULAR LEAD SENSITIVITY DISPLAYED QUESTION MARK SYMBOLS AND THE BATTERY VOLTAGE WAS UNABLE TO BE CHECKED. THE IPG REMAINS IN USE. THE MOBILE PROGRAMMER 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 20256804 ↗
• InjuryAug 13, 2024Pacing Problem; Reset Problem; Pacing Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS BEING REPLACED DUE TO NORMAL RECOMMENDED REPLACEMENT TIME (RRT). IT WAS REPORTED THAT DURING THE REPLACEMENT PROCEDURE, THE IPG EXHIBITED A PACING PROBLEM AND A POWER ON RESET (POR). THE IPG WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19971139 ↗
• MalfunctionJul 24, 2024Pacing Problem; Pacing Problem

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

  Patient problems: Bradycardia

  MAUDE report 19815485 ↗
• MalfunctionJul 16, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR'S PROGRESS BAR DOES NOT FILL WHEN THE READER WAS OVER THE IMPLANT. THE PATIENT HAD DONE ALL TROUBLESHOOTING WITH THE CLINIC AND THE CLINIC ADVISED TO CALL AND ORDER A NEW REMOTE MONITOR. THE PATIENT WAS ASKED IF THE PATIENT HAD THE IMPLANT CHECKED IN OFFICE TO ENSURE IT IS WORKING PROPERLY AND THE PATIENT STATED THAT IT WAS NOT. THE PATIENT WAS GOING TO HAVE THE DEVICE CHECKED IN OFFICE AND THEN CALL BACK FOR A NEW REMOTE MONITOR IF NEEDED. THE MONITOR REMAINS IN USE. IT WAS NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO TELEMETRY. 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 19749769 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO SEVERE TRICUSPID REGURGITATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 19664015 ↗
• InjuryMay 31, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THAT THE PATIENT EXPERIENCED ASYSTOLE DURING A GEN CHANGE. A POLARITY SWITCH WAS NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole

  MAUDE report 19433223 ↗
• InjuryApr 25, 2024Premature Discharge of Battery; Data Problem; Premature Discharge of Battery; Data Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19179544 ↗
• MalfunctionApr 19, 2024Premature Discharge of Battery; Battery Problem; Reset Problem; Premature Discharge of Battery; Battery Problem; Reset Problem

  IT WAS FURTHER REPORTED THAT IPG HAD REACHED END OF SERVICE (EOS) AND DEVICE WENT TO VVI MODE DUE TO DEVICE AT EOS AND NOT DUE TO POR. PREMATURE BATTERY DEPLETION DID NOT OCCUR ON THE IPG. PHYSICIAN FURTHER NOTED PATIENT DOES NOT REQUIRE PACING AND DEVICE TO REMAIN IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19141892 ↗
• MalfunctionApr 18, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FEELING LIKE BEING KICKED IN THE CHEST, CHEST PRESSURE, ARM PAIN AND IS COVERED IN BRUISES. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE SET RATE. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Bruise/Contusion; Chest Pain; Pain

  MAUDE report 19132184 ↗

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-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• 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-2508-2020 · Jun 4, 2020 · Open, Classified
  Azure S DR MRI, Model Number W3DR01
• 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 Number
• 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-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 (e) Mo
• Z-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• 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-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-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.