BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2781729 · Received October 11, 2012

    Report

    Report Number
    2649622-2012-12894
    Event Type
    Injury
    Date Received
    October 11, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4): THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED AND THE DEFIBRILLATION COIL WAS FRACTURED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WITH BILUMEN TUBING VOIDS, THE INNER INSULATION WAS BREACHED, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE OUTER INSULATION WAS BREACHED AND HAD A DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED AFTER BEING EXPLANTED DUE TO AN ELECTIVE REPLACEMENT. THE LEAD SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. 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. 6943

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R 6937 IMPLANTABLE TACHY LEAD