Adapta™ ADDR06 (UDI 00613994222077)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00613994222077), received between Feb 9, 2017 and May 13, 2025 — classified as 1 death, 8 injuries, 4 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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AND THE LEADS WERE ERODED. 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: Erosion; Unspecified Infection

  MAUDE report 22009692 ↗
• MalfunctionJun 20, 2024Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED UNKNOWN POWER ON RESET (POR). 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 19572929 ↗
• DeathFeb 1, 2023Adverse 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 WITH SUSPECTED VEGETATION. IT WAS ALSO NOTED THAT THE PATIENT TESTED POSITIVE FOR METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT A SYSTEM EXPLANT. IT WAS FURTHER NOTED THAT UPON REMOVAL OF THE LEAD THERE WAS AN IMMEDIATE DROP IN BLOOD PRESSURE AND ECHOCARDIOGRAM SHOWED A LARGE HOLE IN THE RIGHT ATRIUM. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED TAMPONADE FROM PERFORATION, PERICARDIAL EFFUSION, HEMOTHORAX AND WAS DECEASED DURING THE SURGICAL PROCEDURE TO REPAIR THE RIGHT ATRIUM.

  Patient problems: Bacterial Infection

  MAUDE report 16276416 ↗
• MalfunctionJun 16, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT NO MAGNET RESPONSE WAS ABLE TO BE ACHIEVED FROM THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVER-SENSING ON STORED ELECTROGRAMS (EGM) AS WELL AS SHORT V-V INTERVALS. THE IPG AND RV LEAD REMAIN USE .NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14710947 ↗
• InjuryApr 14, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE TRANSMISSION SHOWED "NO DATA COLLECTED" FOR MAGNET ELECTROGRAMS (EGM). THE IMPLANTABLE PULSE GENERATOR (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 14111307 ↗
• InjuryAug 16, 2021Battery Problem; Battery Problem

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

  Patient problems: Bradycardia

  MAUDE report 12324795 ↗
• MalfunctionMar 8, 2021Communication or Transmission Problem; Communication or Transmission Problem

  THE PATIENT REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO ESTABLISH 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 11437269 ↗
• MalfunctionSep 1, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE PATIENT'S REPRESENTATIVE THAT "IT RIDES A LITTLE BIT LOW, THE PACEMAKER. IT'S KIND OF FLIPPED SINCE IT WAS PLACED THERE, AND IT'S REALLY LOW". 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 10476086 ↗
• InjuryJun 2, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED BY THE PATIENT'S FAMILY THAT A TELEMETRY ISSUE WAS NOTED ON THE IMPLANTABLE PULSE GENERATOR (IPG). THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10108177 ↗
• InjuryApr 3, 2020Extracardiac stimulation; Extracardiac stimulation

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

  Patient problems: Muscle Stimulation; Undesired Nerve Stimulation

  MAUDE report 9920506 ↗
• InjuryJul 3, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) BATTERY REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) SOONER THAN EXPECTED. THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8758262 ↗
• InjuryApr 10, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7417989 ↗
• InjuryFeb 9, 2017Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT'S CAREGIVER SENT A REMOTE TRANSMISSION, AND EVER SINCE THEN, THE PATIENT'S HEART RATE WENT TO 120-140 BEATS PER MINUTE. IN ADDITION, THE CAREGIVER STATED THAT THEY COULDN'T GET THE HEART RATE BACK DOWN, AND SUSPECTED THAT THE HOME MONITOR CAUSED THE RATE INCREASE. THE PATIENT WAS SENT TO THE EMERGENCY ROOM. NO FOLLOW-UP INFORMATION COULD BE OBTAINED. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 6317764 ↗

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-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-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-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-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-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-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.