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

We found 2 models of Serena Quad CRT-P MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 208 adverse event reports in the FDA's MAUDE database, received between Apr 10, 2018 and Sep 29, 2026 — classified as 4 deaths, 137 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (19 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 Quad CRT-P MRI SureScan problems

Serena Quad CRT-P MRI SureScan models

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

• Serena™ Quad CRT-P MRI SureScan™ W4TR02

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  3 deaths118 reports
• Serena™ Quad CRT-P MRI SureScan™ W4TR02

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 death90 reports

Recent Serena Quad 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.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced infection. The Implantable Pulse Generator (IPG) and Right Ventricular (RV) lead were explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50928852 ↗
• MalfunctionSep 3, 2026Premature Discharge of Battery

  It was reported by the patient that their Cardiac Resynchronization Therapy Pacemaker (CRT-P) has ¿faster than expected battery depletion¿ and they are experiencing dizziness and lightheadedness. Additionally, the patient noted that they previously had diaphragmatic stimulation and adjustments were made. The patient inquired if the adjustments may have affected their CRT-P and health. The CRT-P and Left Ventricular (LV) lead remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: Dizziness

  MAUDE report 50590527 ↗
• InjuryJun 5, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S FAMILY THAT THE PATIENT HAD EPISODES OF PASSING OUT. 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: Syncope/Fainting

  MAUDE report 25408737 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO A SYSTEMIC INFECTION WITH BACTEREMIA PRESENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 25211354 ↗
• MalfunctionMay 18, 2026Pacing Problem

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

  Patient problems: Bradycardia

  MAUDE report 25204208 ↗
• MalfunctionApr 29, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HAD PREMATURE BATTERY DEPLETION. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND HAD AN ATRIAL LEAD POSITION CHECK FAILURE. IT WAS FURTHER NOTED THAT THE BATTERY DEPLETION WAS EXPECTED BASED ON THE RA LEAD, RIGHT VENTRICULAR (RV) LEAD, AND LEFT VENTRICULAR (LV) LEAD IMPEDANCE DROPS AND INCREASED OUTPUTS ON BOTH RA AND RV LEADS. T-WAVE OVERSENSING (TWOS) WAS OBSERVED ON THE ATRIAL CHANNEL. WHILE IN OFFICE, THE RA LEAD WAS REPROGRAMMED, WHICH INCLUDED TURNING OFF THE ATRIAL LEAD POSITION CHECK DUE TO CHRONIC STATUS OF THE LEAD AND THE PREVIOUS ALERT. NO FURTHER ACTION WAS PLANNED AND THE PATIENT WILL CONTINUE TO BE MONITORED. THE DEVICE AND ALL THREE LEADS 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 25033464 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED  VEGETATION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. A TEMPORARY IM PLANTABLE PULSE GENERATOR (IPG) WAS PLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 24814955 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LIGHT HEADEDNESS. IT WAS FURTHER NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND RV LEAD WERE REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 24776165 ↗
• MalfunctionMar 16, 2026False Alarm

  IT WAS REPORTED THAT THERE WAS A LEFT VENTRICULAR (LV) LEAD LOW IMPEDANCE WARNING ON THE DEVICE, HOWEVER, WHEN INTERROGATED THE LEAD TRENDS SHOWED NO OUT OF RANGE IMPEDANCES. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) REMAINS IN USE. IT WAS ALSO NOTED THAT THE LV LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL DECLINE IN IMPEDANCE TRENDS AND THE LV CAPTURE MEASUREMENTS SHOWED AN INCREASE IN IN TRENDS. THE LV AND RV LEADS 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 24611481 ↗
• InjuryMar 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED TWO DAYS LATER. THE REASON WAS NOT PROVIDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606880 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) PATIENT EXPERIENCED A BACTEREMIA INFECTION. THE DEVICE SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 24507593 ↗
• MalfunctionFeb 24, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG), THE SETSCREW WAS DISENGAGED FROM THREADS, THE SETSCREW WAS SIDEWAYS IN PORT, THERE WAS A WRENCH/INTERFACE PROBLEM. THE IPG WAS NOT USED AND A NEW ONE WAS USED IN ITS PLACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24427207 ↗
• MalfunctionFeb 23, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL RISE IN IMPEDANCE. IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS UNABLE TO ESTABLISH TELEMETRY. THE SYSTEM 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 24412851 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SEVERAL YEARS AFTER IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM, THE PATIENT HAD AN INFECTION. THE CRTP SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 24248719 ↗
• InjuryJan 29, 2026Premature Discharge of Battery

  IT WAS FURTHER REPORTED THE THRESHOLDS WERE HIGH (BUT STABLE) SINCE IMPLANT DUE TO PATIENT ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208481 ↗

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