Adapta™ ADSR06 (UDI 00613994222190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00613994222190), received between Aug 9, 2017 and Jul 9, 2026 — classified as 10 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT REPORTS THEY PASSED OUT AND THEIR IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING. THE IPG REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 25764642 ↗
• MalfunctionJul 12, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT SENDING TELEMETRY. IT WAS ALSO REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT WAS REFERRED TO THE CLINIC. THE IPG AND THE REMOTE MONITOR 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 19728464 ↗
• MalfunctionNov 22, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT BE INTERROGATED USING THE MOBILE PROGRAMMER. TROUBLESHOOTING STEPS TAKEN RESOLVED THE ISSUE. 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 18190071 ↗
• MalfunctionFeb 8, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO PACING ON ELECTROCARDIOGRAM (ECG). THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16319861 ↗
• InjuryOct 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENTS SPOUSE THAT THE PATIENT HAD EXPERIENCED AN INFECTION FOR APPROXIMATELY SIX MONTHS. THE IMPLANTABLE PULSE GENERATOR WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15697093 ↗
• InjuryAug 26, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED LOSS OF TELEMETRY. 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 15299745 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE WHEN THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE AND LOSS OF CAPTURE. THE IPG WAS EXPLANTED AND REPLACED. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 15257706 ↗
• MalfunctionMay 19, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ELECTROGRAMS (EGM) WERE INCOMPLETE DURING DEVICE INTERROGATION INDICATING A POSSIBLE DEVICE RECORDING PROBLEM. THE IMPLANTABLE PULSE GENERATOR (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 14434594 ↗
• InjuryAug 27, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA, DIZZINESS AND A FALL. THE RV LEAD EXHIBITED POSSIBLE NON CAPTURE. THE RV LEAD WAS CAPPED AND REPLACED. THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Arrhythmia

  MAUDE report 12376287 ↗
• MalfunctionMar 19, 2021Premature Discharge of Battery; High Capture Threshold; Premature Discharge of Battery; High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) "BATTERY DID NOT LAST AS LONG AS EXPECTED" AND EXHIBITED ELEVATED THRESHOLD. 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 11525836 ↗
• MalfunctionOct 23, 2020Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE/NEAR SYNCOPE. OVERSENSING DURING VENTRICULAR HIGH RATE EPISODES AND UNDERSENSING WERE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO NOTED THAT THE DEVICE IS PACING AFTER UNDERSENSED BEATS AND MAY BE "FIRING WRONG". THE LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 10724997 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND LATER REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10276352 ↗
• MalfunctionJan 13, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR RIGHT VENTRICULAR (RV) LEAD WAS OLD AND THAT THE PHYSICIAN SAID AS A RESULT IT WAS 'BENT AND KINKED' BUT WAS WORKING. THE PATIENT ALSO SAID IF SHE IS NEAR A CELL PHONE IT CAUSES HER IMPLANTABLE PULSE GENERATOR (IPG) TO NOT WORK. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9580041 ↗
• InjurySep 9, 2019Failure to Capture; Battery Problem; Communication or Transmission Problem; Failure to Capture; Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. IT WAS NOTED THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). LOSS OF CAPTURE AND LOSS OF TELEMETRY WERE NOTED. THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 8975015 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION OCCURRED. 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 8421079 ↗
• MalfunctionOct 12, 2018Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT RECEIVED CARDIOPULMONARY RESUSCITATION. UPON IMPLANTABLE PULSE GENERATOR (IPG) INTERROGATION, THERE WAS NOTED VENTRICULAR TACHYCARDIA (VT) DEGRADED TO VENTRICULAR FIBRILLATION (VF), BUT ELECTROMAGNETIC INTERFERENCE COULD NOT BE RULED OUT. IT WAS ALSO REPORTED THAT THERE WAS UNDERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THE IPG AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7961417 ↗
• InjuryApr 10, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE PATIENT WAS HAVING PROBLEMS WITH THE DEVICE "SHOCKING" THEM WHEN THEY WERE TRYING TO SLEEP. THE FAMILY MEMBER ALSO INDICATED THAT A TECHNICIAN CAME OUT AND MADE SOME ADJUSTMENTS, WHICH RESOLVED THE PROBLEM, HOWEVER IT STARTED HAPPENING AGAIN YESTERDAY. NO ADDITIONAL INFORMATION COULD BE OBTAINED THROUGH FOLLOW-UP. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7417023 ↗
• MalfunctionFeb 8, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SET SCREW WOULD NOT ENGAGE WHEN THE LEAD WAS FULLY INSERTED. ANOTHER ADAPTER WAS ATTEMPTED AND THE SET SCREW STILL DID NOT ENGAGE. A DIFFERENT SET SCREW WAS USE AND THE ISSUES WERE RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7256225 ↗
• MalfunctionOct 9, 2017Over-Sensing; Device-Device Incompatibility; Over-Sensing; Device-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT THEY HAVE HAD INTERMITTENT NOISE SHOWING ON THE IMPLANTABLE PULSE GENERATOR (IPG) FOR ABOUT ONE AND HALF YEARS. THEY HAVE NOT BEEN ABLE TO IDENTIFY ANY EXTERNAL INTERFERENCE AND WERE QUESTIONING THE POSSIBILITY OF INCOMPATIBILITY BETWEEN THE IPG AND AN OLD COMPETITOR LEAD. 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 6930760 ↗
• InjuryAug 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE PATIENT THAT THEY NOTED CLICKING FROM THEIR MICROWAVE, AND THEIR HEART RATE FEELS LIKE A "BATTERY CLOCK". FOLLOW-UP INVESTIGATION INDICATED THAT REPROGRAMMING WAS DONE FOR THE DEVICE'S LOWER RATE. 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 6780134 ↗

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-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-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• Z-2509-2020 · Jun 4, 2020 · Open, Classified
  Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
• 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-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-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-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.