Versa™ VEDR01 (UDI 00643169708983)Recalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 00643169708983), received between Feb 8, 2018 and May 16, 2025 — classified as 19 deaths, 54 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (47 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-0811-2019 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 122 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2025Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO INTERROGATE THE IMPLANTABLE PULSE GENERATOR (IPG). MULTIPLE INTERROGATION ATTEMPTS WERE MADE, INCLUDING MANUALLY SELECTING THE MODEL NUMBER; HOWEVER, THESE ATTEMPTS RESULTED IN ¿NOISY TELEMETRY/UNABLE TO INTERROGATE¿ AND ¿PACEMAKER UPDATE NEEDED¿ MESSAGES. A TRANSMISSION WAS SUBSEQUENTLY PERFORMED TO RETRIEVE DEVICE DATA. IT WAS NOTED THAT THE DEVICE DATA FROM FEBRUARY 2025 SHOWED AN ESTIMATED REMAINING LONGEVITY OF 1.6 YEARS. ON MARCH 25, 2025, A SUDDEN SPIKE IN THE RV THRESHOLD TRIGGERED THE DEVICE TO ADAPT ITS OUTPUT, AND THE DEVICE IMMEDIATELY REACHED RECOMMENDED REPLACEMENT TIME (RRT). DURING THE SUBSEQUENT DEVICE CHECK IN APRIL 2025, CLINIC STAFF NOTED NORMAL DEVICE FUNCTION. THE RV LEAD WAS TESTED THROUGH AN ANALYZER AND SHOWED ACCEPTABLE THRESHOLDS. THE IPG WAS REMOVED AND REPLACED. POST-IMPLANT TESTING CONFIRMED ADEQUATE LEAD PERFORMANCE, WITH RVCM (RIGHT VENTRICULAR CONDUCTION MONITORING) AND HIGH THRESHOLD ALERTS ENABLED ON THE NEW DEVICE. THE PATIENT WAS ALSO ENROLLED IN APP-BASED REMOTE MONITORING AS A PRECAUTIONARY MEASURE. THE PROGRAMMER REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22033800 ↗
• MalfunctionFeb 21, 2025Communication or Transmission Problem; Communication or Transmission 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 21430295 ↗
• InjuryJan 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 21177162 ↗
• 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 20809175 ↗
• InjuryMar 8, 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 18865981 ↗
• MalfunctionDec 4, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED BY THE PATIENT THAT THE REMOTE MONITOR HAD TELEMETRY ISSUE AND THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO TELEMETRY.  ADJUSTED THE READER POSITION AND RESET THE REMOTE MONITOR. THE REMOTE MONITOR RECONNECTED. THE REMOTE MONITOR AND IPG REMAINS IN USE. THIS EVENT IS BEING REPORTED 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 18254738 ↗
• InjuryNov 9, 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. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18098876 ↗
• MalfunctionMar 20, 2023Failure to Interrogate; Failure to Interrogate

  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 16577064 ↗
• MalfunctionMar 9, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED BRADYCARDIA.  THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE SET RATE. THE RA LEAD REMAINS IN USE. THE IPG REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 16511635 ↗
• InjuryNov 29, 2022Appropriate 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 15880119 ↗
• MalfunctionApr 15, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE SHOWED VENTRICULAR SENSE COUNTS IN THE LESS THAN 40 BPM BIN ON THE RATE HISTOGRAM. FOLLOW-UP WAS ATTEMPTED; HOWEVER, NO ADDITIONAL INFORMATION COULD BE OBTAINED. THIS INCIDENT WAS NOT REPORTED BY A HEALTH CARE PROVIDER; THEREFORE, NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14121554 ↗
• DeathDec 29, 2021Adverse 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 13111098 ↗
• InjuryApr 6, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE IPG WAS NOT EXPLANTED IN RESPONSE TO THE ADVISORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618189 ↗
• InjuryMar 31, 2021Appropriate 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 REPROGRAMMED. NO DEVICE MALFUNCTION WAS OBSERVED WHILE THE DEVICE WAS IN USE, HOWEVER, THE DEVICE WAS FUNCTIONING IN A MODE SUSCEPTIBLE TO CIRCUIT ERROR AND WAS THEREFORE REPROGRAMMED TO PRECLUDE HARM TO THE PATIENT. 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 11594285 ↗
• DeathJan 28, 2021Adverse 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 11247599 ↗
• MalfunctionJan 12, 2021Pacing Problem; Pacing Problem

  IT WAS LATER REPORTED THAT DURING AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE, AN ADDITIONAL VENTRICULAR SENSE COUNTS IN THE LESS THAN 40 BPM BIN ON THE RATE HISTOGRAM WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11153747 ↗
• MalfunctionJan 11, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE SHOWED VENTRICULAR SENSE COUNTS IN THE LESS THAN 40 BPM BIN ON THE RATE HISTOGRAM. FOLLOW-UP WAS ATTEMPTED; HOWEVER, NO ADDITIONAL INFORMATION COULD BE OBTAINED. THIS INCIDENT WAS NOT REPORTED BY A HEALTH CARE PROVIDER; THEREFORE, NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146675 ↗
• MalfunctionNov 26, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) DID NOT EXHIBIT A LONGEVITY ESTIMATOR VALUE. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT CAPTURE. THE DEVICE AND LEAD 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 10910201 ↗
• DeathSep 29, 2020Appropriate 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: Death

  MAUDE report 10598856 ↗
• InjuryAug 31, 2020Appropriate 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 Consequences Or Impact To Patient

  MAUDE report 10470292 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 Consequences Or Impact To Patient

  MAUDE report 10306959 ↗
• MalfunctionJun 22, 2020Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE SHOWED VENTRICULAR SENSE COUNTS IN THE LESS THAN 40 BPM BIN ON THE RATE HISTOGRAM. FOLLOW UP REVEALED THAT NO INTERVENTION HAS BEEN CONDUCTED. THE DEVICE 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 10178380 ↗
• MalfunctionJun 22, 2020Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE SHOWED VENTRICULAR SENSE COUNTS IN THE LESS THAN 40 BPM BIN ON THE RATE HISTOGRAM. FOLLOW-UP WAS ATTEMPTED; HOWEVER, NO ADDITIONAL INFORMATION COULD BE OBTAINED. THIS INCIDENT WAS NOT REPORTED BY A HEALTH CARE PROVIDER; THEREFORE, NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10178324 ↗
• DeathJun 5, 2020Adverse 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: Death

  MAUDE report 10125361 ↗
• DeathMay 27, 2020Adverse 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: Death

  MAUDE report 10094104 ↗

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-2509-2020 · Jun 4, 2020 · Open, Classified
  Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
• Z-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• Z-2508-2020 · Jun 4, 2020 · Open, Classified
  Azure S DR MRI, Model Number W3DR01
• 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-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-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