BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 5862295 · Received August 9, 2016

    Report

    Report Number
    2649622-2016-10162
    Event Type
    Injury
    Date Received
    August 9, 2016
    Date of Event
    May 19, 2016
    Report Date
    May 19, 2016
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A RISE IN THRESHOLDS SINCE IMPLANT EVENTUALLY LEADING TO HIGH THRESHOLDS. THE LEAD WAS PARTIALLY CAPPED AND REPLACED. THE SUPERIOR VENA CAVA COIL REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515083 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6945-65

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R