Attesta™ SR MRI SureScan™ ATSR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00763000316839), received between Oct 22, 2021 and Sep 17, 2026 — classified as 1 death, 17 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Failure to Interrogate” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection with bactermia and pain. The  Implantable Pulse Generator (IPG) system was explanted.  No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Pain; Unspecified Infection

  MAUDE report 50800048 ↗
• MalfunctionMay 13, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO ESTABLISH TELEMETRY. IT WAS FURTHER NOTED THAT THE REMOTE MONITOR HAD NO TELEMETRY DUE TO A READER POSITION ISSUE, WITH AN INABILITY TO SEND A MANUAL TRANSMISSION AND THE PROGRESS BAR NOT SHOWING. DURING TROUBLESHOOTING, THE READER POSITION WAS ADJUSTED, THE MONITOR WAS REBOOTED, A DRY WASHCLOTH WAS PLACED, AND CHECKING FOR ANY NEARBY ELECTRONIC INTERFERENCE; NO ERROR CODES OR BEEPING SOUNDS WERE NOTED. THE PATIENT WAS REFERRED TO A CLINIC FOR AN IN-OFFICE DEVICE CHECK DUE TO INABILITY TO COMPLETE THE REMOTE DEVICE CHECK/TRANSMISSION. 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 25157656 ↗
• InjuryApr 2, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIOMYOPATHY, COMPLETE HEART BLOCK, CLASS II TO III CONGESTIVE HEART FAILURE, AND A DROP IN EJECTION FRACTION DUE TO THE RIGHT VENTRICULAR (RV) PACING BURDEN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiomyopathy; Heart Block; Heart Failure/Congestive Heart Failure

  MAUDE report 24765579 ↗
• MalfunctionJan 15, 2026High impedance; Mechanical Problem

  IT WAS REPORTED INTRAOPERATIVELY THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A SET SCREW PROBLEM RESULTING IN AN UNDEFINED HIGH VENTRICULAR LEAD IMPEDANCE WARNING. THE IPG WAS ATTEMPTED NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077893 ↗
• InjuryJan 13, 2026Capturing Problem

  IT WAS REPORTED THAT ONE YEAR POST IMPLANT IN A CANINE PATIENT, THE PATIENT BEGAN WINCING. IT WAS ALSO REPORTED THAT THERE WAS A SUDDEN OUTPUT INCREASE AND THRESHOLDS COULD NOT BE CONFIRMED. SYMPTOMS WERE RELIEVED WHEN OUTPUT WAS REDUCED. CAPTURE MANAGEMENT WAS TURNED TO MONITOR. THE LEAD WAS REPROGRAMMED AND THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 24052233 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG)SYSTEM THE PATIENT DEVELOPED AN INFE CTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22937690 ↗
• MalfunctionAug 27, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT LEFT SIDED CHEST PAIN AND A VERY SLOW HEART RATE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH BUT STABLE THRESHOLDS AND NON CAPTURE AND THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED DIMINISHED BATTERY LIFE DUE TO THE ELEVATED RV THRESHOLDS. THE IPG SYSTEM 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 22903510 ↗
• InjuryJun 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT REPORTED THAT THE TEMPORARY PACEMAKER SYSTEM "KEPT FIRING". THE SYSTEM WAS EXPLANTED AND REPLACED WITH A PERMANENT PACEMAKER SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22228118 ↗
• MalfunctionJun 17, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT PRIOR TO USE THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED OUT OF BOX BATTERY DEPLETION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NEVER USED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22220737 ↗
• MalfunctionDec 10, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR AND IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO ESTABLISH TELEMETRY. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT WAS REFERRED TO THE CLINIC. THE MONITOR AND IPG 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 20892237 ↗
• InjuryNov 6, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST IMPLANT THE RIGHT ATRIAL (RA) LEAD AND THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PERFORMANCE ISSUE. THE LEAD AND 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 20619054 ↗
• MalfunctionAug 20, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT AFTER FURTHER INTERROGATION EXHIBITED NORMAL BATTERY LIFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005310 ↗
• InjuryApr 26, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED DECREASED LONGEVITY. 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 19190468 ↗
• InjuryMar 29, 2024Mechanical Problem; Mechanical Problem

  IT WAS FURTHER REPORTED THAT ISSUE PERSISTED AFTER THE IPG WAS REPLACED IT WAS SUSPECTED THAT THE ISSUE WAS RELATED TO THE RV LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002338 ↗
• MalfunctionMar 22, 2024Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED DURING PRE-IMPLANT CHECK THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED OUT OF BOX PRE-MATURE BATTERY DEPLETION. THE DEVICE WAS NEVER IMPLANTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18957729 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST IMPLANT THE PATIENT EXPERIENCED AN INFECTION OF UNKNOWN SOURCE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18777688 ↗
• MalfunctionFeb 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS ABOUT TWO MONTHS AGO EVERYTIME THEY STOOD UP. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT FIRING. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 18629630 ↗
• MalfunctionJan 18, 2024Pacing Problem; Appropriate Device Problem Term/Code Not Available; Pacing Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE NURSE SUGGESTED A DEVICE ISSUE AND NOTED THE IMPLANTABLE PULSE GENERATOR (IPG) WAS CONTINUOUSLY FIRING AFTER THE QRS COMPLEX. 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 18533360 ↗
• MalfunctionDec 15, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED INTRAOPERATIVE THAT THE PHYSICIAN TRIED TO ATTACH THE LEAD TO THE IMPLANTABLE PULSE GENERATOR (IPG) BUT IT DISCONNECTED AND THE SET SCREW DISENGAGED FROM THREADS AND CAME OUT WITH THE WRENCH. THE SET SCREW WAS ATTEMPTED TO BE RESEATED IN THE DEVICE WITHOUT SUCCESS. THE SET SCREW THREADS WERE NOTED TO BE DAMAGED AND STRIPPED. THE IPG WAS ATTEMPTED NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334113 ↗
• DeathNov 22, 2023Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE CAUSE OF DEATH WAS SUSPECTED SUDDEN INFANT DEATH SYNDROME.

  Patient problems: Cardiac Arrest; Loss of consciousness; No Clinical Signs, Symptoms or Conditions; Tachycardia

  MAUDE report 18190445 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ELEVEN DAYS POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM THE PATIENT EXPERIENCED AN INFECTION. THE IPG SYSTEM WAS EXPLANTED AND 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 18092732 ↗
• InjuryNov 2, 2023Pacing 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) EXHIBITED MALFUNCTION THAT HAD LED TO A HEART RATE IN THIRTIES AND FORTIES WITHOUT SYMPTOMS. THE LEFT VENTRICULAR (LV) BIPOLAR LEAD EXHIBITED FRACTURE IN BOTH ARMS. THE IPG AND THE LV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 18056284 ↗
• MalfunctionOct 16, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS NO SUCCESSFUL CARELINK TRANSMISSION. 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 17938817 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM, THE SYSTEM WAS REMOVED DUE TO EROSION, BUT NO CONFIRMED INFECTION. INTRAVENOUS AND ORAL ANTIBIOTICS WERE ADMINISTERED. THERE WAS NO REPLACEMENT SYSTEM IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 17929468 ↗
• MalfunctionJun 15, 2023Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ELECTIVE REPLACEMENT INDICATOR (ERI) WHEN INTERROGATED PRIOR TO IMPLANTATION. THE IPG WAS ATTEMPTED/NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17133409 ↗

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-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• 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-2509-2020 · Jun 4, 2020 · Open, Classified
  Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
• 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 Numb
• Z-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• 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-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 (
• 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.