BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2790714 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14167
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0068-2008
    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. EVALUATION SUMMARY: (B)(4) - PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. STD REVIEW - NO ANOMALIES WERE FOUND. THE FULL LEAD WAS RETURNED IN SEGMENTS AND WAS ANALYZED. THE DISTAL CONDUCTOR WAS DISTORTED, THE OUTER INSULATION EXHIBITED A COSMETIC DEPRESSION, AND THE INNER INSULATION WAS KINKED BUCKLED. BLOOD/BODY FLUID WAS FOUND ON THE OUTER TUBING OVERLAY, WHICH WAS ALSO MELTED AND EXHIBITED COSMETIC ENVIRONMENTAL STRESS CRACKING (ESC). THE OUTER TUBING EXHIBITED AN ESC RELATED BREACH/BREACH (NON-ELECTRICAL), BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM, THE HELIX/LOBE WAS DISTORTED/BENT, AND THE LEAD EXHIBITED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A LOW SENSING VALUE. THE 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. 6931

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R