BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2121835 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07827
    Event Type
    Injury
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: (B)(4): PROXIMAL CONDUCTOR FRACTURED, THE DISTAL CONDUCTOR WAS DISTORTED, THE DEFIBRILLATION COIL WAS DISTORTED, THE DISTAL CONDUCTOR FRACTURED DUE TO OVERSTRESS, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER TUBING HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND ENVIRONMENTAL STRESS CRACKING (NON-ELECTRICAL), THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM; THE ANALYST NOTED INTERMITTENCY BETWEEN THE CONNECTOR PIN AND CAP, WITH POSSIBLE MEDICAL ADHESIVE VISIBLE; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS REPLACED DUE TO FRACTURE. THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5568 IMPLANTABLE PACING LEAD