SensiaRecalls & reported problems across all models

We found 7 models of Sensia by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 843 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2015 and Aug 31, 2026 — classified as 19 deaths, 517 injuries, 307 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (168 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

Sensia recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 17, 2019Open, Classified

   A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality

   Z-0809-2019 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported Sensia problems

Sensia models

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

• Sensia™ SEDR01

  Implantable pulse generator, pacemaker (non-CRT)
  10 deaths434 reports
• Sensia™ SESR01

  Pulse generator, permanent, implantable
  5 deaths315 reports
• Sensia™ SEDR01

  Pulse generator, permanent, implantable
  1 recall0 reports
• Sensia™ SEDR01

  Implantable pulse generator, pacemaker (non-CRT)
  2 deaths36 reports
• Sensia® SESR01

  Implantable pulse generator, pacemaker (non-CRT)
  1 death33 reports
• Sensia™ SESR01

  Pulse generator, permanent, implantable
  1 death13 reports
• Sensia™ SESR01

  Implantable pulse generator, pacemaker (non-CRT)
  12 reports

Recent Sensia adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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