Serena™ CRT-P MRI SureScan™ W1TR02 (UDI 00643169891425)Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00643169891425), received between Aug 12, 2020 and May 14, 2026 — classified as 2 deaths, 37 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (7 reports).

10 other recalls cover devices cleared under the same FDA submission (P010015); 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Signal Artifact/Noise; Electromagnetic Interference

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED ELECTROMAGNETIC INTERFERENCE/NOISE. 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 25168779 ↗
• MalfunctionApr 11, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO BE INTERROGATED. THE IPG WAS NOT USED. THE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851191 ↗
• InjuryApr 10, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WORSENING CARDIOMYOPATHY. THE PATIENT WAS UPGRADED FROM AN IMPLANTABLE PULSE GENERATOR (IPG) TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiomyopathy

  MAUDE report 24838846 ↗
• MalfunctionMar 10, 2026Electromagnetic Interference

  IT WAS REPORTED THAT NOISE/ ELECTROMAGNETIC INTERFERENCE (EMI) WAS OBSERVED ON A STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE, WHICH TRIGGERED EPISODE MISCLASSIFICATION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND RIGHT ATRIAL (RA) 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 24557244 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST IMPLANT THE PATIENT EXPERIENCED DISCOMFORT, PAIN AND REDNESS. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION AND EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Erythema; Pain; Unspecified Infection

  MAUDE report 24012475 ↗
• MalfunctionNov 27, 2025Reset Problem; Reset Problem

  IT WAS REPORTED DURING IMPLANT, THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED AN FULL ELECTRICAL RESET. THE IPG WAS NOT USED AND ANOTHER IPG 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 23665812 ↗
• MalfunctionNov 3, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT ATRIAL TACHYCARDIA. IT WAS ALSO REPORTED THAT ATRIAL EVENTS APPEAR TO BE F ALLING IN BLANKING/REFRACTORY AT TIMES CAUSING INAPPROPRIATE PACING. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 23448352 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED POCKET EROSION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND LATER REPLACED WITH AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 23288837 ↗
• InjuryOct 15, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLDS AND THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXPERIENCED EARLY BATTERY DEPLETION. THE CRT-P WAS EXPLANTED AND REPLACED AND THE RA LEAD 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 23281088 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO A DUE TO A BLOOD BACTERIAL INFECTION, AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS SUBSEQUENTLY IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 23057528 ↗
• InjurySep 2, 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. ITS REPORTED THAT THE SYSTEM WAS INFECTED. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS REMOVED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 22936987 ↗
• InjuryJun 23, 2025Adverse 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 ORGANISM WAS IDENTIFIED AS STAPHYLOCOCCUS AUREUS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND THE LEFT VENTRICULAR (LV) LEAD WAS CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 22310478 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. EROSION AND FEVER WERE ALSO NOTED. THE CRT-P SYSTEM WAS SUBSEQUENTLY REPLACED SIX DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Fever; Medical device site infection

  MAUDE report 22289387 ↗
• MalfunctionMay 15, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HAD A LOOSE SETSCREW AND THERE WAS AN INTERFACE PROBLEM WITH THE SETSCREW AND WRENCH. THE CRT-P WAS NOT IMPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028114 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A POCKET INFECTION AND THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HAD ERODED THROUGH THE POCKET. THE CRT-P SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Medical device site infection; Pocket Erosion

  MAUDE report 21997272 ↗
• MalfunctionApr 25, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A GENERATOR REPLACEMENT PROCEDURE, THE PHYSICIAN APPROACHED THE RIGHT VENTRICULAR (RV) LEAD SETSCREW AT AN ANGLE AND ATTEMPTED MULTIPLE CLOCKWISE AND COUNTERCLOCKWISE ROTATIONS TO TIGHTEN IT. ONLY 1 CLICK WAS HEARD WHEN THE WRENCH WAS ROTATED, BUT THE PHYSICIAN COULD STILL TURN THE WRENCH. THE LEAD WAS GENTLY PULLED TO SEE IF IT WAS SEEDED IN THE HEADER, IT DID NOT MOVE, HOWEVER, THE PHYSICIAN COULD NOT SEE IF THE LEAD WAS ADVANCED ALL THE WAY IN THE HEADER. THE WRENCH WAS ROTATED AGAIN, BUT THERE WAS NO CLICK WITH THE ROTATION. COUNTERCLOCKWISE ROTATIONS WERE ATTEMPTED TO REMOVE THE LEAD BUT THE PHYSICIAN WAS UNABLE TO ROTATE THE SETSCREW. THE SET SCREW WAS THEN PULLED OUT ON THE WRENCH. A NEW CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909485 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING OPEN HEART PROCEDURES THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) PATIENT HAD DEVELOPED AN INFECTION IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS WITH MEDIASTINITIS AND MYOCARDITIS NOTED. THE CRT-P SYSTEM WAS EXPLANTED AND A LEADLESS PACEMAKER WAS IMPLANTED.

  Patient problems: Drug Resistant Bacterial Infection; Myocarditis

  MAUDE report 21529329 ↗
• InjuryJan 30, 2025Migration or Expulsion of Device; Battery Problem; Migration or Expulsion of Device; Battery Problem

  IT WAS REPORTED THAT ABNORMAL BATTERY DEPLETION, DEVICE MIGRATION, INFECTION, EROSION AND HEART FAILURE EXACERBATION WERE NOTED DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Heart Failure/Congestive Heart Failure; Unspecified Infection

  MAUDE report 21277799 ↗
• InjuryDec 10, 2024Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED FROM INFORMATION OBTAINED FROM FOLLOW-UP WITH THE CLINIC THAT DURING THE EXERCISE STRESS TEST, THE PATIENT HAD APPROPRIATE PACING THROUGHOUT, HOWEVER, DURING RECOVERY THERE WERE PERIODS OF ATRIAL SENSING FAILURE WITH SHORT CHANGES IN HEART RATE RESOLVED BY ONE TO TWO MINUTES OF RECOVERY. THE PATIENT WAS PROVIDED A FIVE DAY HOLTER MONITOR FOR FURTHER EVALUATION. THE HOLTER RESULTS WERE NORMAL. THE RIGHT ATRIAL (RA) LEAD REMAINS IN USE. IT WAS ALSO NOTED THAT THE UPPER LIMIT ON THE DEVICE WAS INCREASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898166 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) ""YESTERDAY I HAD TO GO TO EMERGENCY ROOM AFTER THE IMPLANT.  I HAD THUMPING IN MY BELLY. I THOUGHT IT WAS MY AORTA OPERATION BUT IT WAS MY NEW DEVICE. IT JUST NEEDED AN ADJUSTMENT BY THE DOCTOR. IT KEPT ME AWAKE ALL NIGHT, THEY TOLD ME TO GO TO THE EMERGENCY ROOM.  THE CRT-P 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 19994278 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) POCKET HAD ERODED AND WAS INFECTED. THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 19712645 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED AND REPLACED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19472483 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO INFECTION. VEGETATION WAS OBSERVED ON LEADS. TWO DAYS LATER, A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19381014 ↗
• MalfunctionMay 10, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT HAD A NOTED BRADYCARDIA WITH A HEART RATE OF 39 BEATS PER MINUTE (BPM) WHICH WAS BELOW THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) PROGRAMMED LOWER RATE. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 19287264 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POCKET EROSION AT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) POCKET SITE DISCOVERED DURING A FOLLOW UP APPOINTMENT. THE CRT-P SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 19230923 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010015. 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-2513-2020 · Jun 4, 2020 · Open, Classified
  Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
• Z-2512-2020 · Jun 4, 2020 · Open, Classified
  Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
• Z-2511-2020 · Jun 4, 2020 · Open, Classified
  Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
• Z-2415-2018 · Jun 21, 2018 · Terminated
  Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor
• Z-2414-2018 · Jun 21, 2018 · Terminated
  Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and
• Z-2413-2018 · Jun 21, 2018 · Terminated
  Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor
• Z-2412-2018 · Jun 21, 2018 · Terminated
  Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and
• Z-0342-2016 · Nov 9, 2015 · Terminated
  Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.