BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2811757 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17380
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 17, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT AND DISTAL SEGMENTS WERE RETURNED, ANALYZED, AND THE PROXIMAL CONDUCTOR WAS FLEXED AND FRACTURED. IT WAS NOTED THAT THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION CONDUCTOR WAS CUT AND FRACTURED, THE RIGHT VENTRICULAR (RV) CONDUCTOR WAS FRACTURED DUE TO BEING PULLED/STRETCHED/OVERSTRESSED, THERE WAS A COSMETIC WHITE SUBSTANCE ON THE OUTER INSULATION, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE OUTER INSULATION WAS BREACHED CUT, THE PROXIMAL CONDUCTOR WAS FLATTENED, THE OVERLAY TUBING HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION CONDUCTOR WAS FRACTURED DUE TO BEING PULLED/STRETCHED/OVERSTRESSED, AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGEOUT, THE CHRONIC RIGHT VENTRICULAR (RV) LEAD WAS CONNECTED TO THE NEW DEVICE AND AFTER THE POCKET WAS CLOSED THE SUPERIOR VENA CAVA (SVC) IMPEDANCE READ AS "NONE". ON FLUOROSCOPY THE RV LEAD SHOWED AN INSULATION BREACH NEAR THE TRIFURCATION AND EXPOSED AND FRACTURED/FRAYED WIRES. 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 FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB