BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIVE

    MDR report key: 16139791 · Received January 11, 2023

    Report

    Report Number
    2124215-2023-00964
    Event Type
    Injury
    Date Received
    January 11, 2023
    Date of Event
    January 4, 2023
    Report Date
    June 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NKE
    UDI-DI
    00802526536632
    PMA / PMN Number
    P030005/S079
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. INTERROGATION OF THE DEVICE CONFIRMED IT WAS OPERATING IN SAFETY MODE DUE TO SYSTEM RESETS. IT WAS CONFIRMED THAT BRADY THERAPY REMAINED AVAILABLE. THE SYSTEM RESETS OCCURRED DURING A TELEMETRY SESSION AND CAUSED THE DEVICE TO ENTER SAFETY MODE. ENGINEERS DETERMINED THAT THIS DEVICE WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH INTERNAL CELL IMPEDANCE WITHIN THE BATTERY. THE HIGH INTERNAL IMPEDANCE RESULTED IN THE SYSTEM RESETS DUE TO TEMPORARY HIGH-POWER CONSUMPTION RELATED TO TELEMETRY ATTEMPTS AND SUBSEQUENT REVERSION TO SAFETY MODE OPERATION. BOSTON SCIENTIFIC HAS ISSUED A FIELD SAFETY NOTICE REGARDING INGENIO EXTENDED LIFE (EL) AND CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES THAT MAY EXHIBIT THIS BEHAVIOR. THIS PARTICULAR DEVICE IS INCLUDED IN THE HIGH IMPEDANCE IN INGENIO EXTENDED LIFE (EL) PACEMAKER AND CRT-P ADVISORY POPULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HAD A FAULT CODE. THIS DEVICE WAS EXPLANTED AND REPLACED WITH A NEW CRT-P. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HAD A FAULT CODE. THIS DEVICE WAS EXPLANTED AND REPLACED WITH A NEW CRT-P. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118016 INVIVE PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) NKE BOSTON SCIENTIFIC CORPORATION V173 227527 00802526536632

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization| R