BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2130889 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10290
    Event Type
    Injury
    Date Received
    June 16, 2011
    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
    NL
    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. EVALUATION SUMMARY: (B)(4) PARTIAL LEAD WAS RETURNED IN SEGMENTS. PRIMARY ANALYSIS REVEALED THAT THE DISTAL CONDUCTOR WAS FRACTURED. THE DEFIBRILLATION COIL WAS FOUND TO BE DISTORTED AND CUT. THERE WAS BLOOD/BODY FLUID PRESENT ON SEVERAL CONDUCTORS (NOT OBSTRUCTED). THERE WAS A DEFIBRILLATION CONDUCTOR FRACTURE (OVERSTRESS) AND THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY. THE OUTER TUBING WAS KINKED/BUCKLED, MELTED, AND HAD APPARENT COSMETIC ENVIRONMENTAL STRESS CRACKS. ALL INSULATORS WERE BREACHED CUT AND HAD APPARENT COSMETIC DEPRESSIONS. THE HELIX/LOBE WAS DISTORTED/BENT AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR LEAD APPEARED TO HAVE INSULATION DAMAGE IN THE PACE/SENSE CONNECTOR AND AT THE SUPERIOR VENA CAVA COIL. THE LEAD INTEGRITY ALERT IN THE DEFIBRILLATOR HAD TRIPPED. 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. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB