Adapta™ ADSR01 (UDI 00613994222152)Recalls & reported problems

Summary

The FDA's MAUDE database contains 237 adverse event reports that list this exact device (DI 00613994222152), received between Feb 9, 2017 and Dec 22, 2025 — classified as 8 deaths, 149 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (59 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 237 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED END OF LIFE (EOL) AND PACEMAKER MALFUNCTION. 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 23864469 ↗
• MalfunctionAug 18, 2025Pacing Problem; Unable to Obtain Readings; Battery Problem; Pacing Problem; Unable to Obtain Readings; Battery Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA WITH A HEART RATE IN THE FORTIES AND FIFTIES. THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED POSSIBLE PACING BELOW THE LOWER RATE AND INVALID DATA AS BATTERY AND LEAD MEASUREMENTS NOT AVAILABLE. THE DEVICE HAS REACHED RECOMMENDED REPLACEMENT TIME (RRT). IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING BASED ON MARKERS ON NON-MAGNET ELECTROGRAMS (EGM) AND UNDER SENSED VENTRICULAR BEATS NOTED ON EPISODES. THE IPG AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 22833816 ↗
• MalfunctionAug 12, 2025Electromagnetic Interference; Impedance Problem; Electromagnetic Interference; Impedance Problem

  IT WAS REPORTED THAT THERE WAS A LEAD WARNING FOR RIGHT VENTRICULAR (RV) LEAD IMPEDANCE WHICH WAS DURING CAUTERY TO THE PATIENT'S LEFT FOREARM. THE LEAD WAS FUNCTIONING AS EXPECTED WITH ALL MEASUREMENTS WITHIN RANGE. THE IMPLANTABLE PULSE GENERATOR (IPG) 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 22780654 ↗
• InjuryAug 1, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEAT COMING FROM THEIR DEVICE POCKET AND THAT IT WAS ''WARM TO TOUCH'' AFTER BEING OUTSIDE ALL DAY. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE IPG WAS EXPLANTED AND REPLACED.

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

  MAUDE report 22684675 ↗
• InjuryJul 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD NO KNOWN PACEMAKER FOLLOW UP SINCE 2023, WHEN THE BATTERY ESTIMATE WAS NINETEEN MONTHS. THEY WERE NOW EXPERIENCING SYNCOPE AND NEAR SYNCOPE. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Presyncope; Syncope/Fainting

  MAUDE report 22628549 ↗
• InjuryMay 14, 2025Battery Problem; Battery Problem

  IT WAS FURTHER REPORTED THAT THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016518 ↗
• InjuryMar 18, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED EXCESSIVE BATTERY DEPLETION TRIGGERING ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO HIGH PACING OUTPUTS. 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 21637028 ↗
• MalfunctionFeb 4, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED RAPID BATTERY DEPLETION AS A RESULT OF CAPTURE MANAGEMENT UNEXPECTEDLY INCREASING THE PACING OUTPUTS. THE IPG STILL 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 21303716 ↗
• MalfunctionJan 28, 2025Premature Discharge of Battery; Pacing Problem; Communication or Transmission Problem; Premature Discharge of Battery; Pacing Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT UPON ATTEMPTING TO CONNECT THE DEVICE TO THE PROGRAMMER THERE WAS CONCERN THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED BATTERY DEPLETION. PACING SPIKES WERE ALSO NOTED. 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 21252112 ↗
• MalfunctionDec 13, 2024Pacing Problem; Reset Problem; Pacing Problem; Reset Problem

  IT WAS REPORTED THAT A PATIENT WITH A PACEMAKER EXPERIENCED HEART RATES IN THE THIRTIES AT HOME ACCOMPANIED BY LIGHTHEADEDNESS. AN EXTERNAL CARDIAC MONITOR INDICATED PAUSES, AND THERE WAS A POTENTIAL ISSUE OF OVERSENSING WITH THE DEVICE. THE DEVICE UNDERWENT AN ELECTRICAL RESET, AND A LEAD WARNING WAS NOTED WITH IMPEDANCE MEASURING LESS THAN ONE HUNDRED OHMS. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED AND RIGHT VENTRICULAR (RV) LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Non specific EKG/ECG Changes

  MAUDE report 20924597 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SYSTEMIC INFECTION. THE SOURCE OF THE INFECTION IS REPORTED TO BE THE LEG, WHICH WAS AMPUTATED. VEGETATION WAS ALSO NOTED ON THE TIP OF THE RIGHT VENTRICULAR (RV) LEAD. THE 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 20520420 ↗
• InjuryOct 4, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE, SPIKE PACING IMPEDANCE, INTERMITTENT CAPTURE AND NOISE. RV LEAD FRACTURE WAS SUSPECTED. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG), WHICH WAS SCHEDULED FOR A CHANGE OUT DUE TO RECOMMENDED REPLACEMENT TIME, WAS LOCATED ABOVE THE CLAVICLE AND WAS NOT CAPTURING. IT WAS NOTED THAT THE PHYSICIAN WAS ABLE TO PALPATE AND FREELY MOVE THE IPG UNDER THE SKIN WHICH RESULTED IN INTERMITTENT CAPTURING. 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 20366943 ↗
• InjurySep 26, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POTENTIAL PERFORMANCE ISSUES. THE IPG WAS EXPLANTED AND REPLACED. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311495 ↗
• InjurySep 2, 2024Adverse 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) AND RIGHT VENTRICULAR (RV) LEAD WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED, AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20117732 ↗
• InjuryAug 15, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA AND FATIGUE. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE LOWER LIMIT. THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Fatigue

  MAUDE report 19989591 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED ENDOCARDITIS DUE TO AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND AN RV LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 19949275 ↗
• InjuryJun 24, 2024False Alarm; False Alarm

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE LOW IMPEDANCE WARNING. THE IPG WAS EXPLANTED AND REPLACED. THE RIGHT ATRIAL (RA) LEAD WAS CAPPED FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594306 ↗
• InjuryMay 1, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO INTERROGATE. THE DEVICE WAS AT END OF LIFE (EOL). 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 19219802 ↗
• MalfunctionApr 17, 2024Appropriate 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) ''HAS BEEN CAUSING PROBLEMS''. THE 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 19123709 ↗
• InjuryApr 3, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO PACING AT THE LOWER RATE. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 19030680 ↗
• MalfunctionMar 12, 2024Failure to Capture; Over-Sensing; Failure to Capture; Over-Sensing

  IT WAS REPORTED WHEN THE PHYSICIAN WAS OPENING THE DEVICE POCKET DURING A GENERATOR CHANGE AND THE PLASMA BLADE WAS APPLIED, THERE WAS OBSERVED LOSS OF PACING ON THE TELEMETRY. ONCE PLASMA BLADE WAS STOPPED, NORMAL PACING OCCURRED. TELEMETRY STRIPS WERE REVIEWED AND THERE WAS SOME ARTIFACT ON THE RECORDINGS BUT IT DID NOT APPEAR THERE WERE PACING SPIKES OR QRS EVENTS WHEN PLASMA BLADE WAS APPLIED. THE PATIENT WAS NOT SYMPTOMATIC AND THE GENERATOR CHANGE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886604 ↗
• InjuryJan 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE GENERATOR CHANGE OUT THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF) AND THE PATIENT WAS DEFIB RILLATED. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Ventricular Fibrillation

  MAUDE report 18542895 ↗
• InjuryDec 13, 2023Failure to Capture; Failure to Interrogate; Reset Problem; Failure to Capture; Failure to Interrogate; Reset Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH UNSPECIFIED SYMPTOMS. IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS POSSIBLY AT END OF SERVICE, AND EXHIBITED LOSS OF CAPTURE, AND A POWER-ON RESET HAD PREVIOUSLY OCCURRED. IT WAS ALSO REPORTED THAT THE IPG WAS UNABLE TO BE INTERROGATED IN THE ED USING THE PROGRAMMER. THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Fall; Insufficient Information

  MAUDE report 18318077 ↗
• InjuryDec 6, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE IPG WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18274616 ↗
• InjuryNov 23, 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 ITCHING FOR A YEAR AND HALF AT THE IMPLANTABLE PULSE GENERATOR (IPG) AFTER RECEIVING THE COVID VACCINE. THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Itching Sensation

  MAUDE report 18200928 ↗

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-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-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-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-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-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-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-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.