Sensia® SESR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00643169474260), received between Dec 9, 2016 and Apr 14, 2026 — classified as 1 death, 15 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (8 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Failure to Interrogate

  IT WAS REPORTED THAT A PATIENT WITH AN IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED NO TELEMETRY WITH THE MYCARELINK MONITOR AND WAS UNABLE TO SEND A TRANSMISSION BECAUSE THE MONITOR WAS NOT WORKING, WITH THE PROGRESS BAR NOT FILLING COMPLETELY (STUCK AT THE SECOND BAR) AND RETURNING TO THE MAIN SCREEN. DURING TROUBLESHOOTING, THE PATIENT ENSURED NO ELECTRONIC DEVICES WERE CLOSE TO THE UNIT AND ATTEMPTED TO RESEND THE TRANSMISSION, BUT THE ISSUE PERSISTED. THE PATIENT WAS REFERRED TO THE CLINIC TO CHECK THE DEVICE INFORMATION AND WAS ADVISED TO BRING THE MONITOR FOR 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 24872036 ↗
• MalfunctionFeb 13, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT BE INTERROGATED. 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 24331925 ↗
• MalfunctionJan 21, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE CAUSING THE IMPLANTABLE PULSE GENERATOR (IPG) BATTERY TO PREMATURELY DEPLETE. THE DEVICE 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 24131559 ↗
• InjuryMar 10, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE VALUES AND NOISE. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) CAPTURE MANAGEMENT UNEXPECTEDLY GOES TO HIGH PACING OUTPUTS WHICH DEPLETES THE BATTERY EXCESSIVELY. THE RV LEAD WAS CAPPED AND REPLACED. 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 21558522 ↗
• InjuryNov 25, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS NOTED THAT THE RV LEAD WAS INACTIVATED. IT WAS FURTHER REPORTED THAT THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20769997 ↗
• InjuryMar 15, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED NON-PROPHYLACTICALLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18910548 ↗
• MalfunctionApr 3, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA, A VARYING HEART RATE AND TACHYCARDIA. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE LOWER PROGRAMMED RATE AND EXHIBITED NO PACING. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE AND A POLARITY SWITCH. THE IPG AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Tachycardia

  MAUDE report 16664129 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16591156 ↗
• MalfunctionDec 15, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT PACING ON THE MONITOR. 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 15984985 ↗
• MalfunctionMay 13, 2022Pacing Problem; Pacing Problem

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

  Patient problems: Bradycardia

  MAUDE report 14392281 ↗
• InjuryFeb 4, 2022Premature Discharge of Battery; Reset Problem; Premature Discharge of Battery; Reset Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND REQUIRED CARDIOPULMONARY RESUSCITATION (CPR) FOR SIX MINUTES. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION AND WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND COULD NOT BE INTERROGATED. IT WAS ALSO REPORTED THAT THE IPG EXHIBITED A FULL POWER ON RESET (POR). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. THE IPG WAS EXPLANTED AND THE LEADS WERE CAPPED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 13450659 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN (B)(6) INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IPG. ANTIBIOTIC TREATMENT WAS NECESSARY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13058941 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REPEATED CASES OF BACTEREMIA INFECTION. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD SUSPECTED VEGETATION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED BY A LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 11937315 ↗
• InjuryJan 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11207167 ↗
• MalfunctionDec 14, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED POTENTIAL BATTERY DRAIN. THE IPG REMAINS IN USE. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003205 ↗
• MalfunctionJul 1, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) IS "MOVING AROUND" AND FLIPS UNDER THE PATIENTS SKIN. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10217708 ↗
• InjuryApr 14, 2020Pacing Problem; Insufficient Device Problem Information; Pacing Problem; Insufficient Device Problem Information

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO CARDIAC ARREST CAUSED BY HYPOKALEMIA WITH PULSELESS VENTRICULAR TACHYCARDIA. SYMPTOMS EXPERIENCED BY PATIENT WERE NOT DUE ISSUE WITH THEIR IPG.

  Patient problems: Cardiac Arrest; Chest Pain; Dyspnea

  MAUDE report 9957374 ↗
• InjuryMar 31, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9902408 ↗
• InjuryOct 24, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD PREMATURE BATTERY DEPLETION DUE TO THE HIGH RIGHT VENTRICULAR (RV) LEAD THRESHOLDS. THE IPG WAS EXPLANTED AND REPLACED AND THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9232721 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 8594592 ↗
• MalfunctionMar 13, 2019Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS NO TELEMETRY BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE REMOTE MONITOR DURING A MANUAL TRANSMISSION. THE IPG AND REMOTE MONITOR REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8415819 ↗
• MalfunctionDec 17, 2018Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS NOT ABLE TO DETECT THE DEVICE AFTER SEVERAL ATTEMPTS TO TRANSMIT A MANUAL TRANSMISSION. FOLLOW-UP INVESTIGATION WITH THE CLINIC INDICATED THAT THE PATIENT HAS NOT SENT ANY RECENT REMOTE TRANSMISSIONS, OR BEEN SEEN IN THE CLINIC FOR A DEVICE CHECK. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8171563 ↗
• MalfunctionMay 21, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNSUCCESSFUL DUE TO AN UNSPECIFIED SET SCREW ISSUE. THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7530146 ↗
• InjuryMay 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXPERIENCED IMPLANTABLE PULSE GENERATOR (IPG) POCKET DISCOMFORT AND THE POCKET FELT "SQUISHY". THE PATIENT WAS SENT TO THE HOSPITAL WHERE THE POCKET SPONTANEOUSLY OPENED AND BEGAN DRAINING. THE PATIENT HAD AN INFECTION AND WAS TREATED WITH ANTIBIOTICS. THE IPG AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Unspecified Infection; Wound Dehiscence

  MAUDE report 7503761 ↗
• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGERY WAS PERFORMED TO REVISE THE IMPLANTABLE PULSE GENERATOR (IPG) POSITION IN THE POCKET AS IT APPEARED THE DEVICE WAS POSSIBLY ERODING THROUGH THE SKIN AND WAS EVIDENCE OF A POSSIBLE INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 7462144 ↗

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-2508-2020 · Jun 4, 2020 · Open, Classified
  Azure S DR MRI, Model 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-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-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-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-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-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• 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.