BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2200557 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11008
    Event Type
    Injury
    Date Received
    August 11, 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
    GA, US
    Reporter Occupation
    PATIENT

    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 DEVICE WAS RETURNED, ANALYZED, AND NORMAL BATTERY DEPLETION WHICH MEETS EXPECTED LONGEVITY WAS FOUND. (B)(4): THE FULL LEAD IN SEGMENTS WAS RETURNED, ANALYZED, AND THE PROXIMAL CONDUCTOR WAS FRACTURED. IT WAS ALSO NOTED THAT THE DEFIBRILLATOR CONDUCTOR WAS DISTORTED, SEVERAL CONDUCTORS WERE DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND A NON-ELECTRICAL BREACH, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY HEARD AN AUDIBLE ALARM, FELT "ELECTRICAL FEELINGS AROUND MY HEAD" AND THAT THE PATIENT FELL TO THE FLOOR. THE PATIENT IS GOING TO BE EVALUATED BY PHYSICIAN BECAUSE OF THE EVENTS. IT WAS LATER REPORTED THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR AND WAS EXPLANTED AND REPLACED. THE 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
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R IMU49JB IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD