Sensia™ SEDR01 (UDI 00613994177957)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00613994177957), received between Feb 9, 2015 and Sep 6, 2023 — classified as 2 deaths, 29 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Interrogate” (7 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 36 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION. THE IPG SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17688905 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED ATRIAL FIBRILLATION (AF). THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 16580769 ↗
• InjuryMar 3, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) "BATTERY WENT DEAD" AND THE PATIENT DID NOT KNOW ABOUT IT. 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 16478665 ↗
• DeathFeb 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROFESSIONAL WAS UNABLE TO CONFIRM IF THE IPG WAS DAMAGED IN SITU OR DURING THE EXPLANT PROCEDURE. A SCALPEL WAS USED TO REMOVE IT FROM THE PATIENT IN A SINGLE INCISION. IT WAS ALSO REPORTED THAT THE PATIENTS CAUSE OF DEATH WAS OF NATURAL CAUSES (CEREBRAL HEMORRHAGE WITH NO SIGNIFICANT CONDITION), INCLUDING CORONARY ARTERY DISEASE AND GASTRIC ULCERS.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Heart Failure/Congestive Heart Failure

  MAUDE report 16451062 ↗
• MalfunctionJul 13, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED 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 14998280 ↗
• InjuryApr 26, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT WHEN IT WAS TIME FOR THEIR OLD IMPLANTABLE PULSE GENERATOR (IPG) TO BE REPLACED THEY FELT LIKE THEY DID BEFORE THEY HAD A PACEMAKER. IT WAS FURTHER REPORTED THAT THE IPG EXHIBITED PREMATURE BATTERY DEPLETION. THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14203912 ↗
• DeathOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE PATIENT IS DECEASED. THE REPORTER STATED THAT THE "IMPLANTABLE PULSE GENERATOR (IPG) WAS SO MESSED UP" AND THAT THE PATIENT WAS "SUPPOSED TO GET A NEW ONE BUT THEY DIDN'T MAKE IT" . ADDITIONAL INFORMATION RELATED TO THE CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 12704879 ↗
• InjuryAug 13, 2021Battery Problem; Battery Problem

  THE PATIENT REPORTED FEELING CRAPPY AND SHORT OF BREATH AND STATED THEIR IMPLANTABLE PULSE GENERATOR (IPG) BATTERY EXHIBITED PREMATURE BATTERY DEPLETION. THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 12318021 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SYSTEM INFECTION. 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: Unspecified Infection

  MAUDE report 10807808 ↗
• InjurySep 3, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCE BLOOD PRESSURE INCREASE AND A DROP IN HEART RATE BELOW 65 BEATS PER MINUTE. THE PATIENT ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPROGRAMMED. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 10486929 ↗
• InjuryMay 11, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT, THAT THEY HAD A LOT OF TROUBLE WITH THEIR IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT ALLEGED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETED. THE DEVICE 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 10042282 ↗
• InjuryFeb 18, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE PATIENT DID NOT EXPERIENCE BRADYCARDIA. THE IMPLANTABLE PULSE GENERATOR (IPG) HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; No Consequences Or Impact To Patient

  MAUDE report 9719604 ↗
• InjuryNov 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET INFECTION. CULTURES WERE TAKEN AND ANTIBIOTIC TREATMENT WAS ADMINISTERED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A WIRELESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9283349 ↗
• InjuryNov 27, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN EXPECTED. THE IPG WAS REMOVED 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 8105674 ↗
• InjuryNov 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED PASSING OUT IN THEIR KITCHEN. THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope

  MAUDE report 8096165 ↗
• MalfunctionNov 15, 2018Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THERE WERE NO GREEN LIGHTS ON THE TELEMETRY PORTION ON THE MONITOR DURING A MANUAL TRANSMISSION. 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 8076471 ↗
• InjuryOct 18, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE WAS NOTED TO HAVE AN ESTIMATED 21 MONTHS OF REMAINING LONGEVITY. APPROXIMATELY SIX MONTHS LATER, THE ESTIMATED LONGEVITY HAD DECREASED TO 6 MONTHS. AFTER ANOTHER APPROXIMATELY TWO MONTHS, THE DEVICE HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT), WHEREUPON THE PATIENT BECAME SYMPTOMATIC DUE TO THE SWITCH TO VVI PACING MODE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7982447 ↗
• InjurySep 25, 2018Pacing Problem; Communication or Transmission Problem; Appropriate Device Problem Term/Code Not Available; Pacing Problem; Communication or Transmission Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING USE THE IMPLANTABLE PULSE GENERATOR (IPG) TRIGGERED END OF LIFE (EOL) AT UNSPECIFIED TIME. DURING PATIENT FOLLOW UP CHECK, THE IPG ENCOUNTERED TELEMETRY PROBLEM AND NO MAGNET RESPONSE. THE PATIENT HAD A RHYTHM OF APPROXIMATELY 50 BEATS PER MINUTE (BPM) WITH INTERMITTENT SECOND DEGREE BLOCK. IT WAS ALSO REPORTED, THERE WERE NO PACING SPIKES SEEN ON THE MONITOR. THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Exit Block

  MAUDE report 7907169 ↗
• InjuryAug 3, 2018Fracture; High impedance; Failure to Interrogate; Device Displays Incorrect Message; Interrogation Problem; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT BE FULLY INTERROGATED, AND IT HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS QUITE A WHILE AGO. IN ADDITION, LEAD INTEGRITY ALERTS HAD TRIGGERED, AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE. FURTHER FOLLOW-UP INVESTIGATION CONFIRMED THAT THE RA LEAD HAD FRACTURED. THE DEVICE WAS REMOVED AND REPLACED, AND THE RA 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 7746382 ↗
• InjuryAug 1, 2018Failure to Capture; Failure to Interrogate; Interrogation Problem; Failure to Capture; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH ALTERED MENTAL STATUS AND A HEART RATE OF ABOUT 30-40 BEATS PER MINUTE. THE IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT BE INTERROGATED BECAUSE IT WAS AT END OF LIFE (EOL); ADDITIONALLY THE DEVICE WAS NOT PACING SO THERE WAS NO CAPTURE. THE DEVICE WAS INACTIVATED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Confusion/ Disorientation

  MAUDE report 7739506 ↗
• InjuryJun 19, 2018Incorrect Measurement; Unable to Obtain Readings; Battery Problem; Inappropriate or Unexpected Reset; Incorrect Measurement; Unable to Obtain Readings; Battery Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) IS NOW AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND NO LEAD TREND DATA IS AVAILABLE FOR THE ATRIAL LEAD. DATA WAS ABLE TO BE OBTAINED FROM A SAVE TO DISK AND IT SHOWED THAT THE DEVICE HAD A DIAGNOSTIC RESET OCCUR SEVERAL YEARS AGO. ADDITIONALLY, SEVERAL YEARS AGO THE ATRIAL LEAD HAD TRIGGERED AN ATRIAL LEAD WARNING, HAD FAR FIELD R-WAVE (FFRW) OVERSENSING, NOISE AND HIGH/UNDEFINED IMPEDANCE. THERE WAS ALSO A POLARITY SWITCH THAT OCCURRED AS A DIRECT RESULT OF THE ATRIAL LEAD INTEGRITY ISSUE. THE IPG WAS EXPLANTED AND REPLACED. THE ATRIAL LEAD REMAINS IN USE WITH THE NEW IPG. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7617046 ↗
• InjuryMay 22, 2018Failure to Interrogate; Pacing Problem; Failure to Interrogate; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BRADYCARDIA. UPON DEVICE CHECK, THE IMPLANTABLE PULSE GENERATOR (IPG) WOULD NOT INTERROGATE AND DID NOT SEEM TO BE PACING. THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 7531903 ↗
• InjuryMay 15, 2018Failure to Interrogate; Pacing Problem; Failure to Interrogate; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH A BRADYCARDIC HEART RATE AND NO PACEMAKER SPIKES WERE VISIBLE ON THE EXTERNAL MONITOR. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO CONNECT WITH THE PROGRAMMER VIA TELEMETRY. A MAGNET WAS PLACED OVER THE IPG AND THERE WAS NO DISCERNIBLE PACING OUTPUT. THE DEVICE HAD REACHED END OF LIFE (EOL). THE PATIENT HAD BEEN LOST-TO-FOLLOW-UP AND WAS LAST SEEN THREE TO FIVE YEARS AGO, THE PATIENT DID NOT RECALL THE EXACT TIMEFRAME. THE DEVICE WAS EXTRACTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 7516342 ↗
• MalfunctionMay 15, 2018Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT FELT A SHOCKING SENSATION. UPON DEVICE INTERROGATION, CAPTURE WAS UNABLE TO BE VERIFIED FROM THE IMPLANTABLE PULSE GENERATOR (IPG). THE 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 7515532 ↗
• InjuryApr 10, 2018Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PHYSICIAN BELIEVED THAT SOMETHING RELATED TO THE VENTRICULAR SAFETY PACING (VSP) DEVICE FEATURE WAS CAUSING THE PATIENT TO EXPERIENCE INTERMITTENT VENTRICULAR TACHYCARDIA (VT). THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IS PLANNED TO BE EXPLANTED AND REPLACED AS THE DEVICE IS ALSO AT ELECTIVE REPLACEMENT INDICATOR (ERI). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Tachycardia

  MAUDE report 7419055 ↗

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-2509-2020 · Jun 4, 2020 · Open, Classified
  Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
• Z-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• 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-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• 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-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-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-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.