Adapta™ S ADDRS1 (UDI 00613994222091)Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 00613994222091), received between Dec 9, 2016 and Apr 16, 2026 — classified as 7 deaths, 100 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (32 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 142 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Failure to Interrogate

  IT WAS REPORTED THAT THERE WAS NO TELEMETRY AS THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO BE INTERROGATED. IT WAS FURTHER REPORTED THAT THE PROGRAMMER WAS UNABLE TO INTERROGATE WITH THE IPG. THE IPG REMAINS IN USE. THE PROGRAMMER IS EXPECTED TO BE RETURNED FOR EVALUATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894217 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED POSITIVE BLOOD CULTURES FOR STAPHYLOCOCCUS SPECIES. IT WAS NOTED THAT "FLUID" WAS EVIDENT ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS FURTHER NOTED THAT THE IPG WAS THE CONTRIBUTING FACTOR.

  Patient problems: Bacterial Infection; Fluid Discharge; Sepsis; Unspecified Infection

  MAUDE report 24567079 ↗
• InjurySep 18, 2025Battery Problem; Battery Problem

  IT WAS REPORTED BY THE PATIENT'S REPRESENTATIVE THAT THE PATIENT'S "IMPLANTABLE PULSE GENERATOR (IPG) DIED". 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 23082271 ↗
• MalfunctionJun 30, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT FELT THEIR HEART RATE LOWER TO FORTY BEATS PER MINUTE. THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 22356087 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION, SEPSIS AND BACTEREMIA. THE SYSTEM WAS EXPLANTED AN REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Sepsis; Unspecified Infection

  MAUDE report 21933431 ↗
• InjuryOct 1, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE WAS NOT INTERROGATABLE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343980 ↗
• InjuryJul 3, 2024Battery Problem; Adverse Event Without Identified Device or Use Problem; Battery Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI)/ RECOMMENDED REPLACEMENT TIME (RRT) AND THE PATIENT EXPERIENCED SYNCOPAL EPISODES. THE IPG AS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 19665443 ↗
• InjuryJul 3, 2024Reset Problem; Reset Problem

  IT WAS FURTHER REPORTED THAT THAT DURING THE UNRELATED PROCEDURE THE THE IPG EXHIBITED NON FUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 19664330 ↗
• MalfunctionMar 26, 2024Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SUSPECTED OVER-SENSING DURING A PROCEDURE. ELECTROMAGNETIC INTERFERENCE WAS SUSPECTED. THE RIGHT ATRIAL (RA) LEAD EXHIBITED LEAD WARNING. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM 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 18976870 ↗
• InjuryMar 20, 2024Pacing Problem; Battery Problem; Pacing Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND MODE DEFAULTED TO VVI MODE. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED SYNCOPE TWO DAYS FOLLOWING THE MODE SWITCH. THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 18941024 ↗
• MalfunctionOct 4, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS DIFFICULTY INTERROGATING THE IMPLANTABLE PULSE GENERATOR (IPG) WITH A CARELINK MONITOR. THERE WAS NO SUCCESSFUL TRANSMISSION. 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 17866873 ↗
• InjurySep 6, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE WHEN THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI)/RECOMMENDED REPLACEMENT TIME (RRT). IT WAS FURTHER REPORTED THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENTLY HIGH THRESHOLDS. THE IPG AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 17688787 ↗
• InjuryJul 21, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT FUNCTIONING NORMALLY. 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 17369460 ↗
• InjuryFeb 1, 2023Failure to Interrogate; Battery Problem; Appropriate Device Problem Term/Code Not Available; Failure to Interrogate; Battery Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED DUE TO EXPERIENCING SYNCOPAL EPISODES. IT WAS ALSO NOTED THAT THE PATIENT WAS LOST TO FOLLOW UP FOR THE PAST TEN YEARS. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 16276256 ↗
• DeathJan 10, 2023Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENTS DEATH WAS UNRELATED TO THE IPG.

  Patient problems: Bradycardia

  MAUDE report 16129394 ↗
• MalfunctionDec 20, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY. THE PROGRESS BAR WAS NOT MOVING, THEN POWER CYCLE MONITOR, STILL BAR NOT MOVING. THE PATIENT ALREADY TRIED WITH CLOTH. THE PATIENT WAS REFERRED TO THE CLINIC. THE MONITOR REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT REPORTED THAT NO TELEMETRY WAS NOTED ON 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16012373 ↗
• MalfunctionNov 29, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED ARTIFACT. 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 15876050 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF AV CONDUCTION WITH THE EPICARDIAL RIGHT ATRIAL (RA) LEAD EXHIBITING NO PACING AND EPICARDIAL RIGHT VENTRICULAR (RV) LEAD SENSING BEFORE THE LOWER RATE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Block

  MAUDE report 15705956 ↗
• InjuryOct 19, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED POSSIBLE PREMATURE BATTERY DEPLETION AS IT LASTED ONLY FIVE YEARS IN A PATIENT WITH COMPLETE HEART BLOCK. 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 15630781 ↗
• InjurySep 27, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED EARLY 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 15494194 ↗
• InjurySep 19, 2022Premature Discharge of Battery; High impedance; Premature Discharge of Battery; High impedance

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) BATTERY HAD PREMATURE BATTERY DEPLETION. THE IPG WAS REPROGRAMMED AND THEN 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 15445499 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A STAPHYLOCOCCUS EPIDERMIDIS BACTEREMIA INFECTION WITH VEGETATION INVOLVING TRICUSPID VALVE AND THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 15416356 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED COMPLETE HEART BLOCK AS THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE IPG WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Block

  MAUDE report 15292485 ↗
• MalfunctionAug 23, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T WAVE OVERSENSING, UNDERSENSING AND NON CAPTURE. THE IMPLANTABLE PULSE GENERATOR (IPG) ALSO EXHIBITED PACING BELOW THE LOWER RATE. THE RV LEAD AND IPG REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 15274549 ↗
• MalfunctionAug 12, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PALPITATIONS AND THEY FELT THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE IPG AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 15215990 ↗

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-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-2508-2020 · Jun 4, 2020 · Open, Classified
  Azure S DR MRI, Model Number W3DR01
• 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-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-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.