Serena™ Quad CRT-P MRI SureScan™ W4TR02 (UDI 00643169891432)Recalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 00643169891432), received between Feb 11, 2019 and Sep 29, 2026 — classified as 3 deaths, 82 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (9 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 118 reports, 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 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) CHANGEOUT, THE CRT-P SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. THE DEVICE POCKET HAD NOT FULLY HEALED AND REOPENED. ADDITIONALLY, THE PATIENT EXPERIENCED PURULENT DISCHARGE AND WOUND DEHISCENCE. A LEADLESS PACEMAKER WAS IMPLANTED THE SAME DAY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; Purulent Discharge; Wound Dehiscence

  MAUDE report 23992544 ↗
• InjuryDec 2, 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 REMOVED DUE TO INFECTION THE MONTH FOLLOWING A GENERATOR REPLACEMENT PROCEDURE. A NEW PACEMAKER SYSTEM WAS IMPLANTED A FEW WEEKS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23697688 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY PASSED OUT, FELL, AND BROKE TWO OF THEIR RIBS. THE PATIENT INDICATED THAT WHILE AT THE HOSPITAL, HEALTH CARE PROFESSIONALS COULD NOT DETERMINE WHY THEY PASSED OUT, AND THEY WERE REFERRED TO AN ELECTROPHYSIOLOGIST. FOLLOW-UP WITH THE CLINIC REVEALED THAT THE PATIENT RECEIVED A FULL DEVICE CHECK, AND THE PATIENT'S SYNCOPE WAS NOT RELATED TO ANY DEVICE PERFORMANCE ISSUE. 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: Bone Fracture(s); Fall; Syncope/Fainting

  MAUDE report 23560415 ↗
• InjuryNov 14, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION. THE CRT-P 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 23553331 ↗
• MalfunctionNov 4, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH AND A PULSE RATE IN THE FORTY BEATS PER MINUTE (BPM) RANGE, WHICH IS LOWER THAN THE DEVICE'S LOWER RATE LIMIT. THE CLINICIAN SUSPECTED A DEVICE MALFUNCTION. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dyspnea

  MAUDE report 23466451 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COULDN'T SEND A TRANSMISSION WITH THE MOBILE MONITORING APPLICATION. NO TROUBLESHOOTING INDICATED. EDUCATED THE PATIENT ON MOBILE MONITORING APPLICATION FUNCTION. REFERRED THE PATIENT TO WORK WITH THE CLINIC AND IT WAS NOTED THAT THE PATIENT SENT A TRANSMISSION THIS MORNING. THE PATIENT ALSO REPORTED THAT THEY WERE HAVING TROUBLE WITH THEIR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND IT WAS CAUSING DEEP PAINFUL BEATS, AND THEY COULD SEE THEIR CHEST GOING UP AND DOWN. THE CRTP WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Pain

  MAUDE report 23463820 ↗
• InjuryOct 20, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT AFTER SURGERY THEY FELT A PAIN IN THEIR BACK AND SIDE AND LET THEIR DOCTORS KNOW AND "NO ONE COULD FIGURE IT OUT". THE PATIENT FURTHER STATED THAT EVENTUALLY THY FOUND IT WAS THEIR "DEVICE AND THE LEAD STIMULATING NERVES NEAR THE LEAD". THE PATIENT ALSO NOTED THAT WITH THE DEVICE ON THEIR CHEST, THEY COULD FEEL PINCHING. ADDITIONALLY, THE PATIENT NOTED THAT THEY HAD A VIRUS AND WAS GIVEN ANTIBIOTICS. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (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: Viral Infection

  MAUDE report 23342301 ↗
• InjurySep 12, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) BATTERY HAD DEPLETED DUE TO HIGH RIGHT VENTRICULAR (RV) LEAD OUTPUT. HIGH, RISING IMPEDANCE AND NON-CAPTURE WERE ALSO OBSERVED WITH THE RV LEAD. THE CRTP WAS EXPLANTED AND REPLACED WHILE THE RV LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036216 ↗
• MalfunctionSep 8, 2025False Alarm; False Alarm

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED A FALSE LOW LEFT VENTRICULAR (LV) LEAD IMPEDANCE WARNING. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993671 ↗
• MalfunctionSep 5, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED "PINCHING" AROUND THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AREA AND NOTED THAT THE DEVICE "MOVES AROUND". THE PATIENT NOTED THAT THE CRT-P WAS NOT MOVING OUTSIDE THE POCKET BUT THEY WERE SENSITIVE TO THE MOVEMENT. 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 22984235 ↗

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-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-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-2513-2020 · Jun 4, 2020 · Open, Classified
  Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
• 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-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-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-0342-2016 · Nov 9, 2015 · Terminated
  Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.