BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2812178 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17416
    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
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE FULL LEAD IN SEGMENTS WAS RETURNED, ANALYZED AND IT WAS FOUND THAT THE PROXIMAL CONDUCTOR WAS FRACTURED FROM BEING FLEXED. IT WAS NOTED THAT THE PROXIMAL AND DISTAL CONDUCTORS HAD BLOOD (NOT OBSTRUCTED), THE DISTAL CONDUCTOR WAS DISTORTED FROM BEING PULLED/STRETCHED/OVERSTRESSED, AND THE DEFIBRILLATION CONDUCTOR HAD BLOOD (NOT OBSTRUCTED). THE DISTAL END LOW VOLTAGE ELECTRODE WAS COVERED WITH BLOOD AND BODY TISSUE/FIBROTIC GROWTH. THE OUTER INSULATION HAD COSMETIC DEPRESSION AND A COSMETIC WHITE SUBSTANCE. THE OUTER TUBING OVERLAY INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND THE OUTER INSULATION WAS BREACHED FROM BEING CUT. THE HELIX WAS DISTORTED FROM BEING BENT AND PULLED/STRETCHED/OVERSTRESSED. THE EXPOSED RV AND SVC DEFIBRILLATION CONDUCTOR COILS WERE BOTH FRACTURED FROM BEING FLEXED, WERE DISTORTED FROM BEING PULLED/STRETCHED/OVERSTRESSED AND WERE DISTORTED FROM BEING KINKED/BUCKLED. THE LEAD APPEARED TO HAVE BEEN STRETCHED.

    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 THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE HAD BEEN RISING AND WAS AT 2812 OHMS. ALSO, THE RV LEAD THRESHOLD WAS 3.5 VOLTS AT 0.6 MILLISECONDS. THE RV LEAD WAS 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 MEDTRONIC PUERTO RICO, INC. 6945

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB