BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIVE

    MDR report key: 12164023 · Received July 13, 2021

    Report

    Report Number
    2124215-2021-18974
    Event Type
    Injury
    Date Received
    July 13, 2021
    Date of Event
    June 23, 2021
    Report Date
    October 10, 2021
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS IN SAFETY MODE. THE PACING PARAMETERS OF SAFETY MODE WERE UNCOMFORTABLE FOR THE PATIENT AND THE PHYSICIAN PLANNED TO REPLACE THE CRT-P. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS ADDITIONALLY REPORTED THAT THE CRT-P WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS IN SAFETY MODE. THE PACING PARAMETERS OF SAFETY MODE WERE UNCOMFORTABLE FOR THE PATIENT AND THE PHYSICIAN PLANNED TO REPLACE THE CRT-P. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053188 INVIVE IMPLANTABLE DEVICE NKE BOSTON SCIENTIFIC CORPORATION V173 100347 00802526536632

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R