Serena™ Quad CRT-P MRI SureScan™ W4TR02 (UDI 00643169735668)Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00643169735668), received between Apr 10, 2018 and May 29, 2025 — classified as 1 death, 55 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (11 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 90 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 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 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22110047 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POSSIBLE 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 21152704 ↗
• InjuryNov 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED, BY THE PATIENT. THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS "JUMPING". REPROGRAMMING WAS DONE TO RESOLVE THE ISSUE, BUT THE "JUMPING" HAD RETURNED. THE CRT-P REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED, AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 20748008 ↗
• MalfunctionNov 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD A MAGNETIC RESONANCE IMAGING (MRI) EARLIER AND THE PATIENT WAS NOT FEELING WELL SINCE THE SCAN. IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT ACTING NORMALLY WITH NO OTHER FEATURES. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20726072 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A BACTEREMIA INFECTION. THE PATIENT HAD A FEVER AND EROSION AND REDNESS WERE NOTED. THE ORGANISM WAS IDENTIFIED AS STAPHYLOCOCCUS AUREUS. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (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: Bacteremia; Bacterial Infection; Erosion; Erythema; Fever

  MAUDE report 19930605 ↗
• MalfunctionJul 10, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS RETURNED TO THE MANUFACTURER AFTER BEING UPGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715551 ↗
• InjuryJul 5, 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) AND THE LEFT VENTRICULAR (LV) LEAD WERE EXPLANTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19682903 ↗
• MalfunctionMay 14, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), THE PATIENT STATED "I USED TWO YEARS OF BATTERY IN SIX MONTHS OF TIME".  IN JANUARY I HAD TWO YEARS LEFT. IN FEBRUARY, THEY WERE TELLING ME NOT TO WORRY."  THE PATIENT EXPRESSED CONCERNS DUE TO THE DROP IN BATTERY ESTIMATE.  ADDITIONALLY, THE PATIENT STATED "I HAVE BECOME WORRIED BECAUSE I HAVE BECOME EXTRAORDINARILY TIRED."  THE CRT-P REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fatigue

  MAUDE report 19309544 ↗
• InjuryJan 16, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THROUGH FOLLOW UP THAT THE CRT-P WAS ELECTIVELY REPLACED DUE TO DEVICE REACHING RECOMMENDED REPLACEMENT TIME (RRT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522695 ↗
• InjuryNov 2, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS REQUIRED HIGH PACING OUTPUTS, THUS PREMATURELY DEPLETING THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) BATTERY. THE CRT-P WAS EXPLANTED AND REPLACED, THE RV LEAD WAS CAPPED 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 18056285 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POCKET INFECTION AND EROSION WAS NOTICED WITHIN THE PAST TWO MONTHS AND ANTIBIOTICS WERE ADMINISTERED TO NO BENEFIT.  THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), RIGHT ATRIAL (RA) LEAD AND LEFT VENTRICULAR (LV) LEAD WERE EXPLANTED.  THE EPICARDIAL LEAD WAS CUT IN THE BASE OF THE POCKET AND A PORTION REMAINED IN THE PATIENT.  A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 17847996 ↗
• InjurySep 29, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM IN AN UNRESPONSIVE STATE WITH A BRADYCARDIC HEART RATE IN THE TWENTY BEATS PER MINUTE RANGE. IT WAS NOTED THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS PROGRAMMED TO PACE AT A LOWER RATE OF SIXTY BEATS PER MINUTE. THE CRT-P REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Loss of consciousness

  MAUDE report 17842179 ↗
• InjuryJul 5, 2023Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17261679 ↗
• MalfunctionApr 3, 2023Electromagnetic Interference; Pacing Problem; Electromagnetic Interference; Pacing Problem

  IT WAS REPORTED THAT AN INTERROGATION NOTED AN EPISODE OF NOISE THAT WAS LIKELY DUE TO AN EXTERNAL ELECTROMAGNETIC INTERFERENCE SOURCE. INHIBITION OF PACING RESULTED FROM THE EPISODE. THE PATIENT DENIES ANY ELECTROMAGNETIC INTERFERENCE EXPOSURE AND STATES THEY WERE IN BED AT THE TIME OF THE EVENTS. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (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 16668522 ↗
• MalfunctionDec 21, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT POST VALVE REPLACEMENT SURGERY THE PHYSICIAN NOTICED THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) POCKET JUMPING AND PULSATING. THERE WAS CONCERN AND QUESTIONS IF THE CRT-P WAS FUNCTIONING APPROPRIATELY. 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 16024014 ↗
• MalfunctionNov 18, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR COULD NOT ESTABLISH TELEMETRY WITH THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). THE PATIENT WAS ADVISED TO LET THE MONITOR CHARGE FOR ONE HOUR AND TRY AGAIN. THE PATIENT WAS ALSO REFERRED TO THE CLINIC IF IN CASE THE RESOLUTION DID NOT WORK. THE CRT-P REMAINS IN USE. THE REMOTE MONITOR 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 15829633 ↗
• MalfunctionNov 18, 2022False Alarm; Low impedance; False Alarm; Low impedance

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) TRIGGERED A FALSE ALERT FOR LOW IMPEDANCE ON THE RIGHT ATRIAL (RA) LEAD, THOUGH THE LEAD DID HAVE A LOW IMPEDANCE TREND. THE CRT-P AND 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 15828006 ↗
• DeathOct 17, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT IS DECEASED. IT WAS ALLEGED THAT THE DEATH WAS RELATED TO THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 15615573 ↗
• InjuryOct 7, 2022Adverse 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) SYSTEM WAS REMOVED DUE TO A BACTEREMIA INFECTION. CULTURES WERE TAKEN AND THE ORGANISM WAS IDENTIFIED AS GROUP B STREPTOCOCCUS. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED CHILLS, WEAKNESS, FEVER, AND HYPOTENSION. ANTIBIOTIC TREATMENT WAS PROVIDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Chills; Fever; Low Blood Pressure/ Hypotension; Muscle Weakness/Atrophy

  MAUDE report 15564330 ↗
• InjuryAug 2, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED CHRONIC HIGH THRESHOLD MEASUREMENTS RESULTING IN A FAST THAN DESIRED DEPLETION OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) BATTERY. THE LEAD WAS CAPPED AND REPLACED, AND 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 15147191 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD CELLULITIS, WHICH LED TO A SYSTEM INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS SUBSEQUENTLY EXPLANTED DUE TO THE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cellulitis; Unspecified Infection

  MAUDE report 14136543 ↗
• MalfunctionMar 29, 2022Low impedance; Low impedance

  IT WAS REPORTED THAT A LOW IMPEDANCE LEAD WARNING WAS TRIGGERED. IT WAS DETERMINED THAT THE LEAD WARNING HAD BEEN TRIGGERED IN ERROR AND THE LEAD IMPEDANCE HAD NOT BEEN OUT OF RANGE. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13942388 ↗
• InjuryMar 7, 2022Adverse 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 AND REPLACED DUE TO SEPSIS/ENDOCARDITIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Sepsis

  MAUDE report 13677885 ↗
• InjuryJan 7, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION AND A LEAD WAS EXTRACTED FOR AN UNSPECIFIED REASON. THE CRT-P WAS EXPLANTED AND REPLACED. THE PATIENT FURTHER REPORTED THAT ANOTHER LEAD WAS "TAKEN OFF" FOR AN UNSPECIFIED REASON AND THEN ANOTHER LEAD BROKE. THE LEAD THAT WAS "TAKEN OFF" AND THE LEAD THAT BROKE 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 13192815 ↗
• InjuryOct 12, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HAD LOWER THAN EXPECTED LONGEVITY. 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 12615959 ↗

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-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-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-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-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-0342-2016 · Nov 9, 2015 · Terminated
  Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.