Adapta™ S ADDRS1 (UDI 00643169708747)Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 00643169708747), received between Jun 12, 2018 and Jun 24, 2025 — classified as 31 deaths, 57 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (27 reports).

1 FDA recall record name this device's identifier, 1 still open.

15 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.

Recalls naming this device

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-0806-2019 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CAPTURE MANAGEMENT WENT UNEXPECTEDLY HIGH AND DEPLETED THE BATTERY. 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 22319188 ↗
• DeathApr 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; WITH THE CAUSE OF DEATH COULD NOTED TO BE SEPSIS WITH ACUTE RESPIRATORY FAILURE. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE. THIS PATIENT WAS CONFIRMED TO BE PROGRAMMED TO A PACING MODE SUSCEPTIBLE TO THE DESCRIBED ADVISORY ISSUE.

  Patient problems: Respiratory Failure; Sepsis; Septic Shock

  MAUDE report 21882008 ↗
• DeathOct 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE PATIENT PASSED AWAY AND THE CAUSE OF DEATH WAS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493385 ↗
• InjuryOct 1, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE IPG WAS NOT EXPLANTED DUE TO THE CIRCUIT ERROR AND WAS EXPLANTED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344132 ↗
• DeathSep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, A CAUSE OF DEATH COULD NOT BE IDENTIFIED. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE. THIS PATIENT WAS CONFIRMED TO BE PROGRAMMED TO A PACING MODE SUSCEPTIBLE TO THE DESCRIBED ADVISORY ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 20133347 ↗
• MalfunctionApr 5, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED BY THE PATIENT THAT THERE WAS A POSSIBLE TELEMETRY ISSUE WITH 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 19049280 ↗
• MalfunctionFeb 16, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND RISING IMPEDANCES AND RISING CAPTURE THRESHOLDS. IT WAS FURTHER REPORTED THAT MINERALIZATION WAS SUSPECTED AT THE RV LEAD RING ELECTRODE. IT WAS NOTED THAT PROGRAMMING THE RV LEAD TO UNIPOLAR CONFIGURATION SIGNIFICANTLY DECREASED THE IMPLANTABLE PULSE GENERATOR (IPG) BATTERY LONGEVITY, SO THE CONFIGURATION WAS KEPT BIPOLAR. THE LEAD REMAINS IN USE. 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 18722128 ↗
• DeathFeb 1, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: Insufficient Information

  MAUDE report 18623211 ↗
• InjuryDec 18, 2023Premature Discharge of Battery; Battery Problem; Reset Problem; Appropriate Device Problem Term/Code Not Available; Premature Discharge of Battery; Battery Problem; Reset Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED CAPTURE MANAGEMENT GOING UNEXPECTEDLY TO HIGH PACING OUTPUTS WHICH CAUSED PREMATURE BATTERY DEPLETION. IT WAS ALSO NOTED THAT THE PATIENT WAS CONSIDERED FOR UPGRADE TO AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO EXPERIENCING PERSISTENT SEVERE LEFT VENTRICLE SYSTOLIC IMPAIRMENT DUE TO A MYOCARDIAL INFARCTION. THE RV LEAD ALSO EXHIBITED HIGH THRESHOLDS WHICH WAS RELATED TO THE INFARCTION OR THE MEDICATIONS ADMINISTERED DURING THE PREVIOUS CARDIOGENIC SHOCK. THE SYSTEM WAS REPROGRAMMED TO DDD AND A POWER ON RESET OCCURRED.

  Patient problems: Cardiogenic Shock; Heart Failure/Congestive Heart Failure; Myocardial Infarction

  MAUDE report 18343609 ↗
• InjuryDec 14, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED 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 18324937 ↗
• InjurySep 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED FOR AN UNKNOWN REASON. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17834314 ↗
• InjuryMay 5, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE DEPLETION. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE IPG WAS REPROGRAMMED AND THEN EXPLANTED AND REPLACED. THE RV LEAD 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 16876389 ↗
• InjuryApr 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED FOR AN UNKNOWN REASON. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16712890 ↗
• InjuryFeb 28, 2023Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE IPG WAS EXPLANTED DUE TO END OF LIFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451653 ↗
• InjuryFeb 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16426332 ↗
• DeathFeb 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: Arteriosclerosis/ Atherosclerosis; Heart Failure/Congestive Heart Failure

  MAUDE report 16360986 ↗
• InjuryJan 17, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR A DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EVENT, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PROPHYLACTICALLY REPLACED. NO DEVICE MALFUNCTION WAS OBSERVED WHILE THE DEVICE WAS IN USE, HOWEVER, GIVEN THE POTENTIAL FOR LOSS OF DEVICE FUNCTIONALITY, THE IPG WAS EXPLANTED AND REPLACED TO PRECLUDE HARM TO THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183076 ↗
• InjuryDec 1, 2022Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894359 ↗
• InjuryOct 6, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. THE RV LEAD REMAINS IN USE AND THE IPG HAS BEEN 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 15548443 ↗
• InjuryAug 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED FOR AN UNKNOWN REASON. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164653 ↗
• DeathJul 20, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, A CAUSE OF DEATH COULD NOT BE IDENTIFIED. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE. THIS PATIENT WAS CONFIRMED TO BE PROGRAMMED TO A PACING MODE SUSCEPTIBLE TO THE DESCRIBED ADVISORY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064693 ↗
• MalfunctionJul 18, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S REPRESENTATIVE THAT A PACING LEAD "MIGHT NOT BE READING CORRECTLY". THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN USE. IT WAS REPORTED BY THE PATIENT'S REPRESENTATIVE THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS "MALFUNCTIONING" 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 15037544 ↗
• DeathMay 20, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED FOR AN UNKNOWN REASON. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14460863 ↗
• InjuryJan 19, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) ALSO EXHIBITED A MALFUNCTION. THE IPG SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13289959 ↗
• DeathJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: Insufficient Information

  MAUDE report 13255766 ↗

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-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-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-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-2508-2020 · Jun 4, 2020 · Open, Classified
  Azure S DR MRI, Model Number W3DR01
• Z-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• Z-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• 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-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-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-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,
• Z-1515-2009 · May 18, 2009 · Terminated
  Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Rate Responsive Pacemaker, models KDR601, KDR603, KDR606, KDR651, KDR653, KDR701, KDR703, KDR706