Adapta® S ADDRS1Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00643169474192), received between Aug 9, 2017 and Mar 4, 2024 — classified as 1 death, 21 injuries, 13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD A PREMATURE BATTERY DEPLETION. 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 18831471 ↗
• InjuryNov 30, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONIC HIGH THRESHOLDS RESULTING IN PREMATURE BATTERY DEP LETION. THE RIGHT VENTRICULAR (RV) LEAD AND THE IMPLANTABLE PULSE GENERATOR (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 18235832 ↗
• MalfunctionNov 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) WAS LITTLE OUT OF WHACK. 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 18204520 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING OPEN HEART SURGERY WITH THE REMOVAL OF THE EPICARDIAL IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM THE PATIENT EXPERIENCED POST-OP BLEEDING WITH MARKED INCREASE IN CHEST DRAIN OUTPUT ONE HOUR POST OPERATIVE. THE IPG SYSTEM WAS EXPLANTED NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE IPG SYSTEM WAS EXPLANTED DUE TO RECOVERY OF ATRIOVENTRICULAR NODE CONDUCTION FOLLOWING PACING SYSTEM IMPLANT FOR PATIENT CONDITION AND THE EXPLANT PROCEDURE DID NOT CONTRIBUTE TO THE PATIENT'S POST OPERATIVE COMPLICATIONS.

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

  MAUDE report 18168909 ↗
• InjuryMay 23, 2023Impedance Problem; Output Problem; Impedance Problem; Output Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED VARIABLE BATTERY VOLTAGE MEASUREMENTS AND A BATTERY IMPEDANCE ISSUE LEADING TO ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED VARIABLE IMPEDANCE. THE IPG AND RA LEAD WERE REPROGRAMMED AND REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983945 ↗
• MalfunctionDec 13, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A DATA RECORDING PROBLEM AS AN ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE WAS NOT SHOWING ON THE DEVICE INTERROGATION. 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 15972951 ↗
• MalfunctionOct 31, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) DID NOT RECORD THE ELECTROGRAMS (EGM) AND THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE IPG AND RA LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698459 ↗
• MalfunctionOct 11, 2022Failure to Interrogate; Failure to Interrogate

  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 15574473 ↗
• MalfunctionSep 23, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE PATIENTS HUSBAND THAT THE PATIENT EXPERIENCED PAIN AROUND THE IMPLANTABLE PULSE GENERATOR (IPG) SITE DURING THE NIGHT AND IT HAS ALWAYS "BEEN LOOSE, CAN STAND UP ON IT'S SIDE, IT WON'T FLIP OVER BUT I CAN FEEL THE LEADS". THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 15469495 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEPSIS AND AN INFECTION. IT WAS ALSO REPORTED THAT VEGETATION WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. 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: Bacterial Infection; Sepsis

  MAUDE report 14683556 ↗
• MalfunctionApr 14, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNDER REPORTING OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION BURDEN. THE TIME BETWEEN IN OFFICE CHECKS WAS GREATER THAN SIX AND A HALF MONTHS AND THE MODE SWITCH PERCENTAGE WAS EIGHTY FOUR PERCENT. THE CARDIAC COMPASS SHOWED THE ACCURATE CHRONIC ATRIAL FIBRILLATION BURDEN. 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 14111132 ↗
• InjuryDec 30, 2021Adverse 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 EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13117545 ↗
• InjuryJul 21, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND THE IMPLANTABLE PULSE GENERATOR (IPG) HAD MIGRATED LOWER THAN ITS ORIGINAL POSITION. 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 12202585 ↗
• InjuryMay 27, 2021Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NON-CAPTURE. BOTH THE LV 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 11892439 ↗
• InjuryMar 12, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED HIGH THRESHOLDS AND LOW IMPEDANCE WHICH ARE CONTRIBUTING TO THE IPG PREMATURE DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11470438 ↗
• InjuryFeb 9, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHANGES IN BEHAVIOR AND TELEMETRY PAUSES. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INHIBITION OF PACING, LOSS OF CAPTURE OR OVER-SENSING. BOTH THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE RV LEAD WERE INITIALLY REPROGRAMMED AND EIGHT DAYS LATER THE IPG WAS EXPLANTED AND REPLACED, AND THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 11303398 ↗
• InjuryDec 10, 2020Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE, ARRHYTHMIA, HEART BLOCK ASYSTOLE AND THE CARDIOPULMONARY RESUSCITATION WAS PERFORMED. IT WAS NOTED THAT PACING ISSUES WERE OBSERVED ON THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, VARIABLE AND UNSTABLE THRESHOLDS AND INTERMITTENT LOSS OF CAPTURE. RV LEAD WAS REPROGRAMMED AT FIRST AND CAPED AND REPLACED. IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Asystole; Heart Block; Syncope/Fainting

  MAUDE report 10981761 ↗
• MalfunctionSep 29, 2020Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THREE DAYS POST IMPLANT PACING SPIKES WERE COMING AT THE WRONG TIME. POSSIBLE FAR FIELD R-WAVE (FFRW) OVERSENSING WAS ALSO NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10598405 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET INFECTION. ANTIBIOTIC TREATMENT WAS NECESSARY. THE COMPLETE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10501690 ↗
• MalfunctionJun 30, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CLINICIAN COMPLETED A TRANSTELEPHONIC CHECK AND GOT A MAGNET RATE OF SIXTY FIVE BEATS PER MINUTE (BPM) WHICH INDICATES EARLY REPLACEMENT INDICATOR (ERI). IT WAS NOTED THAT THE PATIENT HAS EPICARDIAL LEADS. THE IMPLANTABLE PULSE GENERATOR (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 10211168 ↗
• InjuryMay 29, 2020Adverse 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 REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis

  MAUDE report 10100991 ↗
• MalfunctionMar 13, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE WAS INTERROGATED AND FOUND TO BE AT RECOMMENDED REPLACEMENT TIME (RRT). THE DEVICE WAS NOT USED. THERE WAS NO APPARENT PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9828583 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION FOLLOWING A TRAUMA. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 9810590 ↗
• MalfunctionFeb 24, 2020Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  IT WAS FURTHER REPORTED THAT THERE WAS NO TELEMETRY ISSUES ON THE IMPLANTABLE PULSE GENERATOR (IPG).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9743992 ↗
• InjuryOct 29, 2019False Positive Result; False Positive Result

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE ALERT FOR ELECTIVE REPLACEMENT INDICATOR (ERI). THE ALERT WAS CLEARED AND THE DEVICE REPROGRAMMED, 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 9249023 ↗

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-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• 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-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-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-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-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-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.