BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT ACCEL VR ICD

    MDR report key: 6900554 · Received September 28, 2017

    Report

    Report Number
    2938836-2017-32269
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    September 20, 2017
    Report Date
    September 28, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE LEAD AND DEVICE WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING FOLLOW-UP, LOSS OF CAPTURE WAS NOTED ON THE RIGHT VENTRICULAR LEAD. THE DEVICE WAS REPROGRAMMED AND THE PATIENT WAS IN STABLE CONDITION. RELATED MANUFACTURER REPORT NUMBER: 2938836-2017-032268.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682018 CURRENT ACCEL VR ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC. CD1215-36Q 3447488

    Patients

    Seq Age Sex Outcome Treatment
    1 7122Q/58 DURATA STS OPTIM LEAD (SN: (B)(4))