Attesta™ S DR MRI SureScan™ ATDRS1Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00763000316822), received between Jan 18, 2021 and Aug 17, 2026 — classified as 2 deaths, 22 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (3 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Damaged Thread

  It was reported that during the implant procedure, the Implantable Pulse Generator (IPG) exhibited a setscrew issue where the setscrew's threads were damaged and stripped. The device was not implanted but another device was successfully implanted. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50277021 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25278958 ↗
• InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE MONTH POST IMPLANT, THE PATIENT EXPERIENCED A SYSTEMIC INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25271318 ↗
• InjuryMar 30, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE DEPLETION. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED. BOTH WERE 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 24728500 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST-IMPLANT THE PATIENT EXPERIENCED A POCKET INFECTION OF UNKNOWN ORIGIN. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED REDNESS. 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: Erythema; Medical device site infection

  MAUDE report 24244396 ↗
• InjurySep 8, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD A ''MALFUNCTION''. THE DEVICE WAS EXPLANTED AND REPLACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991682 ↗
• InjuryAug 26, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT NON CAPTURE AND OUT OF RANGE (OOR) HIGH IMPEDANCES. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT FUNCTIONING WITHIN NORMAL TOLERANCES. THE RV LEAD AND IPG WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893330 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. VEGETATION WAS ALSO NOTED ON THE RIGHT ATRIAL (RA) LEAD. 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 21396708 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY FOUR MONTHS POST IMPLANT THAT THE PATIENT EXPERIENCED EROSION AND REDNESS. THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED. THE RIGHT ATRIAL (RA) LEAD WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Erythema

  MAUDE report 21303005 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION APPROXIMATELY SIX WEEKS POST IMPLANTABLE PULSE GENERATOR (IPG) CHANGEOUT. THE IPG SYSTEM AND A PREVIOUSLY CAPPED RIGHT ATRIAL (RA) LEAD WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21125320 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXTRACTED DUE TO SYSTEM INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20682774 ↗
• InjuryNov 1, 2024Failure to Capture; Mechanical Problem; Under-Sensing; Failure to Capture; Mechanical Problem; Under-Sensing

  IT WAS REPORTED THAT TWO DAYS POST IMPLANTABLE PULSE GENERATOR (IPG) CHANGEOUT, THE EPICARDIAL PACING LEADS AND NEW IPG HAD FAILED PER TELEMETRY WITH NO SENSING OR CAPTURE. IT WAS ALSO NOTED THAT THE EPICARDIAL RIGHT ATRIAL (RA) PACING LEAD EXHIBITED NO PACING WHICH WAS CAUSED BY POSSIBLE TISSUE UNDER THE ELECTRODE DETERIORATING WITH EDEMA AND PROBABLE EPICARDIAL CELL NECROSIS. THE RA LEAD WAS CAPPED AND REPLACED. A DENT WAS NOTED ON THE IPG BODY AND IT WAS EXPLANTED AND REPLACED. THE RIGHT VENTRICULAR (RV) LEAD 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 20587435 ↗
• MalfunctionSep 11, 2024Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THERE WERE NO PERFORMANCE ISSUES. THE PACING BEHAVIOR WITNESSED OCCURRED DURING A COMMANDED BATTERY CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189913 ↗
• DeathFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT THE PATIENT DIED. PRIOR TO THE PATIENT'S PASSING, THE PATIENT¿S RELATIVE NOTED THAT THE PATIENT¿S IMPLANTABLE PULSE GENERATOR (IPG) WENT INTO ¿BATTERY SAVING MODE¿ FOR A YEAR AND THE PATIENT "WASN'T ABLE TO STAND OR WALK" AND THEY COULDN¿T GET THE PATIENT DRESSED. THE PATIENT REPRESENTATIVE FURTHER REPORTED THAT THE PATIENT WAS "CHOKING ON THEIR SALIVA" AND COULDN¿T HOLD THEIR HEAD UP AND THE PATIENT WAS SO WEAK, THEY BECAME BED RIDDEN. THE PATIENT¿S IPG WAS EVENTUALLY EXPLANTED AND REPLACED, BUT WAS PUT ON HOSPICE CARE AFTER THIS. SIX DAYS LATER, THE PATIENT PASSED AWAY DUE TO UNKNOWN REASONS. ADDITIONAL INFORMATION RELATED TO THE CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 18806967 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED DUE TO AN INFECTION. THE ORGANISM WAS IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS AND THE PATIENT HAD A FEVER. IT WAS NOTED THAT A STERNOTOMY WAS REDONE, THE AREA WAS WASHED OUT AND TEMPORARY PACING LEADS WERE PLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection; Fever

  MAUDE report 18799080 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED EROSION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 18363105 ↗
• MalfunctionDec 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS NO PERFORMANCE ISSUE WITH THE IPG AND BRADYCARDIA SYMPTOMS NOT RELATED TO THE IPG. LOW HEART RATE READINGS WERE RELATED TO ECTOPIC BEATS RELATED TO PATIENT CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18264685 ↗
• MalfunctionOct 24, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY AND THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO TEL EMETRY. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT WAS REFERRED TO THE CLINIC. THE MONITOR AND 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 17994090 ↗
• MalfunctionSep 22, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE PATIENT 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 17797184 ↗
• InjuryMar 24, 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 AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM, THE PATIENT DEVELOPED A POCKET INFECTION. CULTURES WERE OBTAINED AND THE ENTIRE IPG SYSTEM WERE EXPLANTED. THE PATIENT RECEIVED ANTIBIOTIC TREATMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 16610926 ↗
• MalfunctionFeb 21, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT COMMENCED RADIATION THERAPY FOR BREAST CANCER AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPOSITIONED TO THE RIGHT PECTORAL SITE PRIOR TO THERAPY. OVER A YEAR LATER, THE IPG WAS UNABLE TO BE INTERROGATED IN CLINIC BY A PROGRAMMER. THE ELECTROCARDIOGRAM (ECG) INDICATED THERE WAS APPROPRIATE PACING AT THE PROGRAMMED RATE. THE IPG COULD NOT BE VISUALIZED OR PALPATED ON INSPECTION IN THE CLINIC AND INTERROGATION REMAINED UNSUCCESSFUL IN MULTIPLE POSITIONS, INCLUDING LYING DOWN. 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 16407187 ↗
• MalfunctionJan 19, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS CONCERNED ABOUT THE BATTERY LONGEVITY OF AN IMPLANTABLE PULSE GENERATOR (IPG) APPROXIMATELY ONE DAY POST IMPLANT. 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 16205658 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY SEVEN WEEKS POST IMPLANT THAT THE PATIENT DEVELOPED A POCKET INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD WERE REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15548318 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pocket Erosion

  MAUDE report 15435948 ↗
• MalfunctionJul 27, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE PATIENT THAT TWO WEEKS POST IMPLANT THEY HAVE MORE PROTRUSION" FROM THE IMPLANTABLE PULSE GENERATOR (IPG) THAN THEY WOULD HAVE THOUGHT. IT WAS FURTHER REPORTED THAT THEY EXPERIENCED "SIDE EFFECTS" FROM HAVING A FOREIGN OBJECT IN THEIR BODY. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15110922 ↗

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-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-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-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-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-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-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-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.