Sensia™ SESR01 (UDI 00643169708945)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169708945), received between Dec 7, 2017 and Apr 24, 2026 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Interrogate” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET EROSION AND AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) AND RIGHT ATRIAL (RA) LEAD WERE REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; Pocket Erosion

  MAUDE report 24979396 ↗
• MalfunctionNov 27, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE UNABLE TO INTERROGATE THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS NOTED THAT A PATIENT MAGNET HAD BEEN PLACED OVER THE PATIENT¿S DEVICE. NO PACING WAS OBSERVED, AND NO CHANGE WAS OBSERVED IN THE PATIENT¿S HEART RATE. THE PROGRAMMER AND RF HEAD ARE EXPECTED TO BE RETURNED 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 23664806 ↗
• InjuryMay 17, 2024High impedance; Battery Problem: High Impedance; High Capture Threshold; High impedance; Battery Problem: High Impedance; High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED HIGH IMPEDANCE AND HIGH BATTERY THRESHOLDS. 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 19338840 ↗
• InjuryJan 15, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE. THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A SUSPECTED FAILURE AND APPEARED TO BE INTERMITTENTLY PACING. THE RV LEAD AND IPG REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 18510364 ↗
• MalfunctionMar 1, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A DATA COLLECTION ISSUE FOR THE LEAD IMPEDANCE DATA. 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 16458148 ↗
• InjuryMay 27, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH (SOB). THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED ELEVATED THRESHOLDS IN BIPOLAR CONFIGURATION. INITIALLY, THE RV LEAD WAS REPROGRAMMED TO UNIPOLAR CONFIGURATION, AND CAPTURE MANAGEMENT INCREASED UNIPOLAR OUTPUTS TO APPROXIMATELY MAXIMUM, TRIGGERING RECOMMENDED REPLACEMENT TIME (RRT) IN THE IMPLANTABLE PULSE GENERATOR (IPG), TRIGGERING MODE CHANGE, CAUSING THE PATIENT'S SOB. APPROXIMATELY SIX WEEKS LATER, THE RV LEAD WAS CAPPED AND REPLACED AND THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 14521802 ↗
• InjurySep 14, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. PREMATURE BATTERY DEPLETION WAS ALSO NOTED ON THE IM PLANTABLE PULSE GENERATOR (IPG). BOTH THE RV LEAD AND IPG WERE 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 12468402 ↗
• InjuryMar 9, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC PAIN AT IMPLANT SITE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDERSENSING AND HIGH THRESHOLDS. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 11442287 ↗
• InjuryJan 13, 2021Failure to Capture; Failure to Interrogate; Pacing Problem; Device Sensing Problem; Impedance Problem; Failure to Capture; Failure to Interrogate; Pacing Problem; Device Sensing Problem; Impedance Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED THREE SECOND PAUSES ON TELEMETRY WITH NO PACING AND POSSIBLE LOSS OF CAPTURE,SENSING ISSUES AND DECLINED IMPEDANCE. THE IPG WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 11162092 ↗
• MalfunctionSep 1, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT FEELS UNCOMFORTABLE DUE TO DEVICE MOVING OR INTEGRATION FROM ABDOMEN TO LOWER BREAST. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 10475786 ↗
• InjuryOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPAL EPISODES. IT WAS THOUGHT THAT THE IMPLANTED SYSTEM MAY HAVE EXHIBITED NON-CAPTURE. HOWEVER, IT WAS DETERMINED THAT THE PATIENT WAS IN BIGEMINY WHICH GAVE THE ILLUSION OF NON-CAPTURE. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope

  MAUDE report 8004937 ↗
• InjuryDec 7, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PHYSICIAN INADVERTENTLY PLACED A SINGLE CHAMBER IMPLANTABLE PULSE GENERATOR (IPG) INSTEAD OF A DUAL CHAMBER IPG. THE PHYSICIAN SUBSEQUENTLY EXPLANTED AND REPLACED THE SINGLE CHAMBER DEVICE WITH A DUAL CHAMBER DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7092659 ↗

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-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-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-1924-2025 · Apr 29, 2025 · Open, Classified
  Azure S DR MRI SureScan, Product number W3DR01
• Z-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• Z-2509-2020 · Jun 4, 2020 · Open, Classified
  Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
• Z-2508-2020 · Jun 4, 2020 · Open, Classified
  Azure S DR MRI, Model Number W3DR01
• Z-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• 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-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-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-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.