Attesta™ DR MRI SureScan™ ATDR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00763000316808), received between May 19, 2021 and Mar 26, 2026 — classified as 18 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (7 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Unable to Obtain Readings; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO RUN LEAD IMPEDANCE, THRESHOLD TESTING, OR BATTERY IMPEDANCE MEASUREMENTS. A POP UP APPEARED "UNABLE TO TEST" AND "POLARITY CONFIGURATION". IT WAS ALSO NOTED THAT THERE WAS AN RECOMMENDED REPL ACEMENT TIME (RRT) TIMESTAMP IN THE DEVICE MEMORY SUGGESTIVE OF COLD TEMPERATURE EXPOSURE WHILE STILL PACKAGED. THE 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 24699594 ↗
• MalfunctionMar 4, 2026Failure to Capture

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED LOSS OF CAPTURE. THE 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 24511295 ↗
• MalfunctionOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED WORSENING CARDIOMYOPATHY WITH EJECTION FRACTION AT FORTY TO FORTY FIVE BEATS PER MINUTE. THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiomyopathy

  MAUDE report 23379577 ↗
• MalfunctionAug 13, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED ABNORMAL BATTERY DEPLETION. 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 22791390 ↗
• InjuryJun 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS FURTHER REPORTED THAT THE IPG DID NOT DISLODGE. THE IPG WAS REPLACED BY AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335198 ↗
• InjuryJun 25, 2025Premature Discharge of Battery; Premature 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 22326387 ↗
• MalfunctionJun 6, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE LOWER RATE. IT WAS NOTED THE PATIENT EXPERIENCED BRADYCARDIA, TACHYCARDIA, SHORTNESS OF BREATH AND DIZZINESS. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness; Dyspnea; Tachycardia

  MAUDE report 22156800 ↗
• InjuryMay 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PROGRAMMER FROZE DURING A RIGHT VENTRICULAR (RV) THRESHOLD TEST ON A PATIENT. THE THRESHOLD TEST WAS INITIATED, BUT WOULD NOT CEASE AFTER CAPTURE WAS LOST. IT WAS NOTED THAT AFTER THE TEST BUTTON WAS RELEASED, THE AMPLITUDE CONTINUED TO DECREMENT, AND THE SCREEN OF THE ENCORE PROGRAMMER WAS FROZEN. THE PROGRAMMER REMAINED UNRESPONSIVE DESPITE MULTIPLE ATTEMPTS TO STOP THE THRESHOLD TEST, WHICH RESULTED IN ASYSTOLE AND SYNCOPE. IT WAS ALSO NOTED THAT THE PROGRAMMER DISPLAYED ERROR STATING SERIOUS PROGRAMMER PROBLEM. THE PROGRAMMER WAS THEN ABLE TO REBOOT AND OPEN TO THE NORMAL "FIND PATIENT" SCREEN. PATIENT WAS CONSCIOUS AGAIN WITHOUT ANY MEDICAL INTERVENTION. THE PROGRAMMER IS EXPECTED TO BE RETURNED FOR EVALUATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.* THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole; Syncope/Fainting

  MAUDE report 22009401 ↗
• MalfunctionDec 11, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT THAT, FIVE DAYS POST IMPLANTABLE PULSE GENERATOR (IPG) CHANGEOUT, THAT THEIR IPG WAS PACING BELOW THE LOWER RATE AS THEIR HEART RATE WAS BELOW SIXTY. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 20901364 ↗
• InjuryNov 18, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED, THAT THE PATIENT EXPERIENCED BRADYCARDIA, DIZZINESS AND PRE-SYNCOPE. IT WAS NOTED, THERE WAS HIGH THRESHOLDS, INTERMITTENT CAPTURE , NO CAPTURE. AND A HEADER ISSUE WITH THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED, AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706381 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Erosion; Fever; Unspecified Infection

  MAUDE report 20662717 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED NEAR EROSION OF ONE OF THE PACING LEADS AND HAD A REVISION TWO DAYS PRIOR TO THE INFECTION. IT WAS ALSO REPORTED THAT THE INFECTION WAS STAPH AUREUS IN THE BLOOD. THE RIGHT ATRIAL (RA) LEAD ALSO DISLODGED DURING THE EXPLANT PROCEDURE AND DRAINAGE WAS PERFORMED.

  Patient problems: Bacterial Infection; Discomfort; Erythema; Pain; Pocket Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 19603539 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WORSENING CARDIOMYOPATHY WITH RIGHT VENTRICULAR PACING. IT WAS ATTEMPTED TO UPGRADE THE  IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM BUT COMPLETE OCCLUSION OF THE MID TO DISTAL SUBCLAVIAN WAS NOTED AND THERE WAS NO ACCESS FOR THE NEW TRANSVENOUS LEADS. THE IPG WAS EXPLANTED AND REPLACED . THE CHRONIC RIGHT ATRIAL (RA)  AND RIGHT VENTRICULAR (RV) LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiomyopathy

  MAUDE report 19162240 ↗
• InjuryMar 28, 2024Failure to Capture; Pacing Problem; Failure to Capture; Pacing Problem

  IT WAS REPORTED POST OPERATIVELY THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED OUTPUT FAILURE AND WOULD NOT CAPTURE. 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 18991190 ↗
• MalfunctionMar 11, 2024Break; Communication or Transmission Problem; Break; Communication or Transmission Problem

  IT WAS REPORTED INTRA OPERATIVELY THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PHYSICAL DAMAGE AND EXHIBITED A TELEMETRY ISSUE. 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 18875339 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED ANTIBIOTIC TREATMENT. THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Bacterial Infection; Drug Resistant Bacterial Infection

  MAUDE report 18844401 ↗
• InjuryFeb 6, 2024Pacing Problem; Device-Device Incompatibility; Pacing Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ACCIDENTALLY PROGRAMMED TO THE WRONG MODE PRIOR TO AN MAGNETIC RESONANCE IMAGING (MRI) SCAN. SURE SCAN MODE WAS TURNED OFF AND THE PATIENT EXPERIENCED DIZZINESS AND SYNCOPE. THE PATIENT RECOVERED AND THE IPG WAS REPROGRAMMED WITH THE MRI TAKE PLACE SUCCESSFULLY. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Syncope/Fainting

  MAUDE report 18650123 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED WORSENING CARDIOMYOPATHY WITH OBLIGATORY RIGHT VENTRICULAR (RV) PACING. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH AN UPGRADE TO CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiomyopathy

  MAUDE report 18473880 ↗
• InjuryJan 8, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT SIX WEEKS POST IMPLANT THE PATIENT'S INCISION SITE WAS NOT HEALING. IT WAS NOTED THAT THERE WAS NO ISSUES UNTIL THE CURRENT IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. THE IPG SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Impaired Healing; Wound Dehiscence

  MAUDE report 18465617 ↗
• MalfunctionJan 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED "LOTS OF PAIN AND COULDN'T BREATHE". IT WAS ALSO REPORTED THAT "THEY THINK THE PACEMAKER IS MALFUNCTIONING". THE IMPLANTABLE PULSE GENERATOR (IPG) REMAIN IN SERVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Pain

  MAUDE report 18442179 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. 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 18363337 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. 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: Unspecified Infection

  MAUDE report 18117816 ↗
• MalfunctionOct 19, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) MIGRATED FROM THE IMPLANT SITE A LITTLE DOWN BELOW THE SCAR. 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 17964294 ↗
• InjurySep 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT PATIENT EXPERIENCED PAIN AT THE PACEMAKER SITE.

  Patient problems: Discomfort; Erythema; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 17675694 ↗
• MalfunctionAug 25, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE PATIENT REPORTED APPROXIMATELY SIX MONTHS POST IMPLANT THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO SEND A TRANSMISSION DUE TO 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 17621974 ↗

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-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-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-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-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-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-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 (
• 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.