BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2053340 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05872
    Event Type
    Injury
    Date Received
    April 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND THE DEFIBRILLATOR CONDUCTOR HAD FRACTURED. IT WAS ALSO NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED, THE DEFIBRILLATOR CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID IN THE OUTER TUBING OVERLAY, THE OUTER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, A NON ELECTRICAL BREACH, AND WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM. THE ANALYST ALSO NOTED THAT IT CANNOT BE DETERMINED AT THIS TIME HOW BLOOD ENTERED THE RV LEG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD SHOWED HIGH DEFIBRILLATION THRESHOLDS. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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. 6931 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R