Serena CRT-P MRI SureScanRecalls & reported problems across all models

We found 2 models of Serena CRT-P MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 111 adverse event reports in the FDA's MAUDE database, received between Oct 6, 2017 and May 14, 2026 — classified as 2 deaths, 68 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Serena CRT-P MRI SureScan problems

Serena CRT-P MRI SureScan models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Serena™ CRT-P MRI SureScan™ W1TR02

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  2 deaths59 reports
• Serena™ CRT-P MRI SureScan™ W1TR02

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  52 reports

Recent Serena CRT-P MRI SureScan adverse event reports

The 15 most recent reports across all models, 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 31, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT BY THE PATIENT THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE DEPLETION. 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 24740173 ↗
• 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 ↗

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