BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2864945 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17521
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 25, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. IT WAS ALSO NOTED THAT THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY FRACTURED DUE TO A CUT, THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL BECAME EXTRINSICALLY FRACTURED DUE TO A CUT, THE PROXIMAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED WITH A WHITE SUBSTANCE, THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD, THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH, THE DISTAL ELECTRODE OF THE LEAD WAS MISSING THE MCRD (MONOLITHIC CONTROLLED RELEASE DEVICE) THAT CONTAINS THE STEROID, THE INNER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT, THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT, THE OVERLAY TUBING OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO ACUTE, THE OVERLAY TUBING OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO MELTING, THE OUTER INSULATION OF THE LEAD DEVELOPED A COSMETIC DEPRESSION WHILE IN VIVO, THE OVERLAY TUBING OF THE LEAD DEVELOPED COSMETIC ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO, THE OVERLAY TUBING OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 4473 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE HAD A SIGNIFICANT RISE OVER A THREE MONTH PERIOD. IT WAS ALSO NOTED THAT THE LEAD WAS FUNCTIONING AT THE TIME OF REPLACEMENT. 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 FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R 7278 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR