Serena™ CRT-P MRI SureScan™ W1TR02 (UDI 00643169735651)Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00643169735651), received between Oct 6, 2017 and Mar 31, 2026 — classified as 31 injuries, 21 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 52 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjurySep 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE CRT-P WAS EXPLANTED AND REPLACED.

  Patient problems: Tachycardia

  MAUDE report 20276319 ↗
• MalfunctionAug 23, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS.  THE RV LEAD REMAINS IN USE.  IT WAS ALSO REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) REMOTE TRANSMISSION SHOWED POSSIBLE INVALID DATA NOTED, MISSING SECTIONS OF OPTIVOL FLUID INDEX AND THORACIC IMPEDANCE GRAPHS.  THE CRT-P 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 20046888 ↗
• MalfunctionMay 7, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT'S REPORTED HEART RATE WAS IN THE 30-60S WHICH WAS LOWER THAN THE PROGRAMMED RATE. 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: Bradycardia

  MAUDE report 19262331 ↗
• MalfunctionApr 19, 2024Premature Discharge of Battery; Premature Discharge of Battery

  ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN OFFICE NOTED THAT THERE IS NO CONCERN WITH AN UNEXPECTED BATTERY DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19145377 ↗
• InjuryNov 22, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING PACING IMPEDANCE AND HIGH THRESHOLDS. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE LV LEAD WAS CAPPED AND REPLACED. DURING THE REMOVAL OF THE RV LEAD, THE ATRIAL LEAD WAS ALSO REMOVED TO HELP MAINTAIN VASCULAR ACCESS. THE RV LEAD AND ATRIAL LEADS WERE ALSO REPLACED. IT WAS ALSO NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) REACHED RAPID BATTERY DEPLETION DUE TO THE HIGH RV AND LV THRESHOLDS. THE DEVICE WAS 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 18196199 ↗
• MalfunctionOct 25, 2023Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available

  THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED AND REPLACED DUE TO THE BATTERY REACHING RECOMMENDED REPLACEMENT TIME (RRT). THE CRT-P WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007449 ↗
• MalfunctionAug 24, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) ELECTROCARDIOGRAM (EKG) REPORTED PACEMAKER FAILURE. HEALTHCARE PROFESSIONAL STATED DEVICE APPEARS TO BE PACING AT SIXTY-ONE BEATS PER MINUTE (BPM).  THE CRT-P REMAINS IN USE.  AN LEFT VENTRICULAR (LV) LEAD ALERT TRIGGERED FOR HIGH CAPTURE THRESHOLD.  THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASE IN CAPTURE THRESHOLD.  THE LV LEAD AND RV 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 17618989 ↗
• InjuryJul 14, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT HIGH LEFT VENTRICULAR (LV) LEAD AND RIGHT VENTRICULAR (RV) LEAD THRESHOLDS CONTRIBUTED TO PREMATURE CARDIAC RES YNCHRONIZATION THERAPY PACEMAKER (CRT-P) BATTERY DEPLETION. THE RV LEAD WAS CAPPED AND REPLACED, THE DEVICE WAS EXPLANTED AND REPLACED AND THE LV 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 17328079 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE EXPLANTED AND THE RIGHT ATRIAL (RA), LEFT VENTRICULAR (LV), AND RIGHT VENTRICULAR (RV) LEADS WERE CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16953355 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pocket Erosion

  MAUDE report 16712886 ↗
• InjuryJan 30, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED AND REPLACED DUE TO REACHING EARLY ELECTIVE REPLACEMENT INDICATOR (ERI). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269201 ↗
• MalfunctionDec 20, 2022Low impedance; Low impedance

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) FALSELY TRIGGERED A LOW OUT OF RANGE IMPEDANCE ALERT FOR THE LEFT VENTRICULAR (LV) LEAD. THE DEVICE DATA HAD BEEN REVIEWED AND IT WAS DETERMINED THAT THERE WERE NO TRUE OUT OF RANGE IMPEDANCE ALERTS FOR THE LV LEAD. THE CRT-P 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 16017910 ↗
• InjurySep 26, 2022Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15482610 ↗
• InjuryAug 16, 2022Reset Problem; Reset Problem

  IT WAS REPORTED THAT INTERROGATION OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) REVEALED A ¿FLASH MEMORY FAILURE¿ AND INDICATED A ¿SERIOUS DEVICE MEMORY FAILURE¿ OCCURRED. THE DEVICE HAD A RESET CAUSING THE PATIENT TO FEEL TIRED. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fatigue

  MAUDE report 15235264 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 15020386 ↗
• InjuryDec 16, 2021Adverse 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) DEVICE AND LEADS WERE EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13018857 ↗
• InjuryNov 2, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS LATER EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737981 ↗
• InjuryOct 5, 2021Premature Discharge of Battery; Premature Discharge of Battery

  ADDITIONAL INFORMATION RECEIVED INDICATED INTERVENTION WAS PERFORMED FOR HIS LEAD THE OUTPUT SETTINGS WERE RE-PROGRAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579484 ↗
• InjuryAug 9, 2021Adverse 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. A NEW SYSTEM WAS IMPLANTED ON THE PATIENT'S OPPOSITE SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12294493 ↗
• MalfunctionJun 21, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT'S HEART RATE TEMPORARILY DROPPED BELOW THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) LOWER PROGRAMMER RATE. THE CRT-P REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 12032208 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CRT-P SYSTEM WAS EXPLANTED DUE TO A POCKET EROSION AND AN INFECTION. THE PATIENT WAS ADMINISTERED ANTIBIOTICS, CULTURES WERE TAKEN, A TEMPORARY PACER WAS PLACED, AND NEW SYSTEM WAS IMPLANTED FIVE DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 11921514 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED, CULTURES WERE TAKEN AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE SYSTEM WAS LATER REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11372478 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED SEVERE PAIN AT THE SITE OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) IMPLANT. IT WAS NOTED THAT THE SKIN ADJACENT TO THE INCISION AND OVERLAYING THE CRT-P WAS VERY SENSITIVE, SLIGHTLY BLANCHED, AND ANY MOVEMENT OR TOUCHING CAUSED SIGNIFICANT SHOOTING PAIN. THE PATIENT STATED THAT THE CRT-P WAS TOO CLOSE TO THE SURFACE OF THE SKIN. A POCKET REVISION WAS DONE AND THE CRT-P 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: Pain

  MAUDE report 10830584 ↗
• InjuryAug 3, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE PATIENT HAD LIFTED HEAVY OBJECTS AND THE RIGHT VENTRICULAR (RV) LEAD AND HIS RV LEAD BOTH DISLODGED. THE RV LEAD WAS REPOSITIONED AND REMAINS IN USE. THE HIS RV LEAD WAS EXPLANTED. AN ACCEPTABLE POSITION COULD NOT BE FOUND FOR A NEW HIS RV LEAD AND DUE TO TORTUOUS ANATOMY, A NEW LV LEAD WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10356457 ↗

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-2511-2020 · Jun 4, 2020 · Open, Classified
  Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
• Z-2512-2020 · Jun 4, 2020 · Open, Classified
  Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
• Z-2513-2020 · Jun 4, 2020 · Open, Classified
  Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
• 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-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-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.