BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALITUDE X4 CRT-P

    MDR report key: 23577907 · Received November 17, 2025

    Report

    Report Number
    2124215-2025-83933
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 23, 2025
    Report Date
    February 24, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NKE
    UDI-DI
    00802526559402
    PMA / PMN Number
    P030005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION TO H6: ADDED A0711/INTERROGATION PROBLEM. REMOVED A160503/INAPPROPRIATE OR UNEXPECTED RESET AND A23/USE OF DEVICE PROBLEM.

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION TO H6: ADDED A0711/INTERROGATION PROBLEM. REMOVED A160503/INAPPROPRIATE OR UNEXPECTED RESET AND A23/USE OF DEVICE PROBLEM. THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE WAS OPERATING IN SAFETY MODE AND WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH BATTERY IMPEDANCE, WHICH PUT THIS DEVICE AT RISK OF EXPERIENCING TRANSIENT VOLTAGE DECREASES (AND ASSOCIATED RESETS) DURING TELEMETRY OR OTHER NORMAL, HIGHER-POWER OPERATIONS. WHEN BATTERY VOLTAGE DROPS BELOW A MINIMUM THRESHOLD, A SYSTEM RESET IS PERFORMED. IF THREE SYSTEM RESETS OCCUR WITHIN A 48-HOUR PERIOD, THE DEVICE IS DESIGNED TO ENTER SAFETY MODE OPERATION TO MAINTAIN BACK-UP PACING WITH PRE-DEFINED SETTINGS. BOSTON SCIENTIFIC HAS ISSUED A FIELD SAFETY NOTICE TO NOTIFY PHYSICIANS OF THE POTENTIAL FOR ACCOLADE FAMILY PACEMAKER AND CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES TO EXHIBIT THIS BEHAVIOR.

    Additional Manufacturer Narrative · 0

    THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION REGARDING EVENT CAUSE/RESOLUTION AND PRODUCT RETURN STATUS. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED AN ALERT MESSAGE INDICATING THAT BATTERY REPLACEMENT INDICATOR HAD BEEN REACHED ON (B)(6) 2000 AND THAT REMOTE MONITORING WAS DISABLED. THIS WAS A FALSE POSITIVE EXPLANT INDICATOR RELATED TO A SOFTWARE UPDATE. ADDITIONALLY, THIS CRT-P EXPERIENCED AN OSCILLATOR MISMATCH CONDITION CONSISTENT WITH HIGH BATTERY IMPEDANCE. APPROXIMATELY TWO WEEKS LATER, THIS CRT-P WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PRODUCT RETURN WAS REQUESTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED AN ALERT MESSAGE INDICATING THAT BATTERY REPLACEMENT INDICATOR HAD BEEN REACHED ON (B)(6) 2000, AND THAT REMOTE MONITORING WAS DISABLED. THIS WAS A FALSE POSITIVE EXPLANT INDICATOR RELATED TO A SOFTWARE UPDATE. ADDITIONALLY, THIS CRT-P EXPERIENCED AN OSCILLATOR MISMATCH CONDITION CONSISTENT WITH HIGH BATTERY IMPEDANCE. APPROXIMATELY TWO WEEKS LATER, THIS CRT-P WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PRODUCT RETURN WAS REQUESTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED AN ALERT MESSAGE INDICATING THAT BATTERY REPLACEMENT INDICATOR HAD BEEN REACHED ON (B)(6) 2000 AND THAT REMOTE MONITORING WAS DISABLED. THIS WAS A FALSE POSITIVE EXPLANT INDICATOR RELATED TO A SOFTWARE UPDATE. ADDITIONALLY, THIS CRT-P EXPERIENCED AN OSCILLATOR MISMATCH CONDITION CONSISTENT WITH HIGH BATTERY IMPEDANCE. APPROXIMATELY TWO WEEKS LATER, THIS CRT-P WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863639 VALITUDE X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) NKE BOSTON SCIENTIFIC CORPORATION U128 703001 00802526559402

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Required Intervention| H