BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2790463 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14736
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD IN SEGMENTS WAS RETURNED, ANALYZED AND OUTER INSULATION BREACH FOUND. IT WAS NOTED THAT THE DISTAL LEAD CONDUCTOR WAS PULLED/STRETCHED/OVERSTRESSED, FRACTURED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS DETECTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE EXTRACTION OF THE RV LEAD THE ATRIAL LEAD CAME OUT, AND SUBSEQUENTLY WAS ALSO EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R 1861 COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD