BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2812992 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15977
    Event Type
    Injury
    Date Received
    October 31, 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
    MI, 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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. THE OUTER TUBING HAD ENVIRONMENTAL STRESS CRACKING (NON-ELECTRICAL). THE DISTAL CONDUCTOR WAS DISTORTED. THE OUTER TUBING OVERLAY HAD BLOOD/BODY FLUID, WAS MELTED, HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, AND WAS BREACHED CUT. THE OUTER INSULATION HAD COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. VISUAL ANALYSIS NOTED THE LEAD HAD APPARENT EXPLANT DAMAGE. A BREACH IN THE OUTER TUBING WAS OBSERVED. THIS DOES NOT ACT AS AN INSULATION AND DOES NOT COMPROMISE THE INTEGRITY OF THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD IMPEDANCE VARIATIONS. ONCE THE POCKET WAS OPENED, THE PHYSICIAN VISUALIZED AN INSULATION BREACH OF THE RV LEAD ON THE MAIN LEAD BODY. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) TISSUE VALVE