BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2811541 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15870
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) - THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY WAS MELTED AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR DELIVERED THERAPY DUE TO OVERSENSING. IT WAS ALSO REPORTED THAT THE LEAD'S IMPEDANCE WAS GRADUALLY DECREASING BELOW TWO HUNDRED OHMS AND WAS SUSPECT OF AN APPARENT INSULATION FAILURE. THE LEAD WAS PARTIALLY 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6945

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R D154ATG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6940 IMPLANTABLE PACING LEAD