Adapta™ ADDR01 (UDI 00643169708624)Recalls & reported problems

Summary

The FDA's MAUDE database contains 364 adverse event reports that list this exact device (DI 00643169708624), received between Dec 7, 2017 and Sep 14, 2026 — classified as 84 deaths, 181 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (99 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 364 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Premature 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 50750368 ↗
• MalfunctionMay 25, 2026Failure to Interrogate

  IT WAS REPORTED THAT THAT THERE WAS NO TELEMETRY WITH MYCARELINK DUE TO A READER POSITION ISSUE, AND THE DEVICE WAS BEEPING DURING THE ATTEMPTED TRANSMISSION. TROUBLESHOOTING WAS PERFORMED BY GUIDING THE PATIENT THROUGH PRESSING BUTTONS ON THE DEVICE, MOVING THEHANDSET/READER, AND UNPLUGGING AND REPLUGGING THE MONITOR. THE MONITOR WAS ASSESSED AS FUNCTIONING PROPERLY, AND THE PATIENT WAS REFERRED BACK TO THE CLINIC FOR FURTHER EVALUATION, INCLUDING CHECKING THE PACEMAKER BATTERY AND SETTINGS WITH A SPECIALIZED PROGRAMMER. 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 25270859 ↗
• InjuryOct 15, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCK FROM THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS FURTHER NOTED 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 IPG WAS PROPHYLACTICALLY REPROGRAMMED. THE DEVICE WAS FUNCTIONING IN A MODE SUSCEPTIBLE TO CIRCUIT ERROR AND WAS THEREFORE REPROGRAMMED 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 23301030 ↗
• InjuryJul 3, 2025Appropriate 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 22394274 ↗
• InjuryJun 17, 2025Appropriate 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 22229720 ↗
• MalfunctionMay 19, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBTED HIGH THRESHOLDS LEADING TO PREMATURE DEPLETION. 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 22043821 ↗
• InjuryMay 16, 2025Appropriate 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 22033707 ↗
• InjuryApr 22, 2025Pacing Problem; Appropriate Device Problem Term/Code Not Available; Pacing Problem; 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 21881403 ↗
• MalfunctionApr 18, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD NO TELEMETRY. POWER CYCLE THE MONITOR AND THE PATIENT REPRESENTATIVE MOVED THE ELECTRONICAL DEVICES AWAY FROM THE MONITOR. TRIED WITH A DRY WASHCLOTH BUT STILL NOT WORKING. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. PATIENT WAS REFERRED TO CLINIC. THE REMOTE MONITOR REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER 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 21863427 ↗
• DeathJan 10, 2025Appropriate 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21122120 ↗
• InjuryNov 29, 2024Appropriate 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 20809614 ↗
• MalfunctionNov 13, 2024Failure to Interrogate; Adverse Event Without Identified Device or Use Problem; Failure to Interrogate; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO 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 20674094 ↗
• DeathOct 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  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 20472356 ↗
• InjuryJul 26, 2024Failure to Interrogate; Failure to Interrogate

  THE PATIENT WAS REPORTED TO BE DECEASED. IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO ESTABLISH TELEMETRY AND COULD NOT BE INTERROGATED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS CAPPED AND REPLACED BY A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT WAS DECEASED TWELVE DAYS POST-IMPLANT OF THE LEADLESS IPG.

  Patient problems: Insufficient Information

  MAUDE report 19836667 ↗
• InjuryJun 24, 2024Appropriate 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 19599860 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Sepsis

  MAUDE report 19219682 ↗
• InjuryApr 30, 2024Appropriate 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 19211337 ↗
• MalfunctionMar 8, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE TOLD THEIR HEART RATE WAS IN THE FORTIES IN BEATS PER MINUTE (BPM) WHEN THEY WENT TO CLINIC FOR IRON INFUSIONS. THE PATIENT NOTED THAT IN THE PAST THEY FELT "LIKE THE PACEMAKER ISN'T KEEPING UP." THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 18865181 ↗
• MalfunctionMar 6, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED A HEART RATE OF FORTY NINE AND FIFTY BEATS PER MINUTE PER BLOOD PRESSURE CUFF. THEY STATED "EVEN AFTER RESTING FOR SEVERAL MINUTES AND RETAKING IT, IT HAS NOT INCREASED" AND THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS "SET TO 60". THEY STATED THAT IN THE EMERGENCY DEPARTMENT THEY WERE INFORMED THEY HAD A SEVERE CASE OF VERTIGO. THEY ALSO STATED THEY GOT SICK AND "THAT'S WHERE ALL THIS STARTED, IRREGULAR HEART RATE AND GETTING DIZZY ALL THE TIME". THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness; Vertigo

  MAUDE report 18847143 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERSISTENT NON-ISCHEMIC CARDIOMYOPATHY, WHICH WAS PRESUMED TO BE PACING INDUCED, AND A REDUCTION IN EJECTION FRACTION SINCE IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT WAS PUT ON MEDICAL THERAPY AND THE IPG WAS EXPLANTED AND REPLACED WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 18442218 ↗
• MalfunctionDec 4, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEART RATES IN THE FIFTIES. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE LOWER RATE LIMIT. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 18254402 ↗
• MalfunctionNov 14, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA WITH RATES DOWN TO THIRTY BEATS PER MINUTE AND FREQUENT PREMATURE VENTRICULAR CONTRACTIONS (PVC). THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE LOWER RATE OF FIFTY FIVE BPM. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A DECREASE IN CAPTURE THRESHOLDS AND 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: Arrhythmia; Bradycardia

  MAUDE report 18130005 ↗
• InjuryNov 14, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENTS POCKET AND ADAPTERS BELOW THE RECTUS SHEATH IN THE UPPER QUADRANT OF THE PATIENTS ABDOMEN WERE CALCIFIED. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 18129135 ↗
• InjuryOct 23, 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. 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. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17983430 ↗
• MalfunctionOct 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. NO DEVICE MALFUNCTION WAS OBSERVED WHILE THE DEVICE WAS IN USE, HOWEVER, THE DEVICE WAS FUNCTIONING IN A MODE SUSCEPTIBLE TO CIRCUIT ERROR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948367 ↗

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-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-2508-2020 · Jun 4, 2020 · Open, Classified
  Azure S DR MRI, Model Number W3DR01
• Z-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• 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-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,
• 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