BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2954315 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02222
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    October 22, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. THE AWARE DATE OF THE INITIAL EVENT WAS 2012 (B)(6). OF NOTE, THE POCKET EROSION RESULTING IN THE LEAD¿S REMOVAL AND REPLACEMENT (SERIOUS INJURY) IS NORMALLY SUBMITTED VIA THE ASR INF <(>&<)> EROS SUBMISSION THAT WOULD HAVE BEEN DUE ON 2013-01-31. THE FINAL ANALYSIS RESULTS WERE SUBSEQUENTLY RECEIVED ON 2013-01-15, AND REVEALED AN OUT OF SPECIFICATION (OOSP) FINDING. THE OOSP FINDING RESULTS IN MODEL 6949 NO LONGER QUALIFYING FOR ASR INF <(>&<)> EROS REPORTING; THEREFORE, MODEL 6949 IS BEING SUBMITTED AS A TIMELY EVENT WITH THE BIMONTHLY SUBMISSION DUE 2013-02-10. PRODUCT EVENT SUMMARY #(B)(4) - THE FULL LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. THE PROXIMAL CONDUCTOR WAS FLEXED AND FRACTURED. THE DISTAL CONDUCTOR HAD OVER-ROTATION. THE OVER-LAY TUBING WAS MELTED, KINKED/BUCKLED, HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, AND BLOOD INGRESSION. THE OUTER INSULATION HAD COSMETIC DEPRESSION. THE DISTAL ELECTRODE WAS COVERED WITH BLOOD, A VISUALLY THE LEAD WAS STRETCHED. (B)(4).

    Description of Event or Problem · 1

    EROSION OF THE POCKET WAS REPORTED. THE LEAD WAS REMOVED AND REPLACED. THE FULL LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59346 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR