BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1072937 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03343
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    April 4, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0067-007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. EVALUATION SUMMARY: PROXIMAL CONDUCTOR FRACTURED; FULL LEAD ANALYZED H3 OTHER TEXT: IT WAS REPORTED THE LEAD HAD HIGH IMPEDANCES OVER SEVERAL DAYS AND THE PATIENT FELT SYNCOPAL AND DIZZY. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT REPORTED SHE WAS DOING WELL. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION COMPONENT/SUBASSEMBLY FAILURE LEAD CONDUCTOR DEVICE WAS OUT OF SPECIFICATION IN A MANNER THAT RELATES TO EVENT IMPEDANCE, HIGH.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD HAD HIGH IMPEDANCES OVER SEVERAL DAYS AND THE PATIENT FELT SYNCOPAL AND DIZZY. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT REPORTED SHE WAS DOING WELL.

    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 27 YR Required Intervention 4076 IMPLANTABLE PACING LEAD| D154ATG IMPLANTABLE PACEMAKER/CARDIO/DEFIB