BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1050035 · Received May 8, 2008

    Report

    Report Number
    2649622-2008-02597
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 28, 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
    GA, 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 SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: PROXIMAL CONDUCTOR FRACTURED; FULL LEAD RETURNED AND ANALYZED. IT WAS REPORTED THE LEAD WAS EXPLANTED AND REPLACED DUE TO INAPPROPRIATE SHOCKS, OVERSENSING, HIGH IMPEDANCE, AND LEAD FRACTURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. 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 LEAD(S), FRACTURE OF OVERSENSING SHOCK, INAPPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS EXPLANTED AND REPLACED DUE TO INAPPROPRIATE SHOCKS, OVERSENSING, HIGH IMPEDANCE, AND LEAD FRACTURE. NO FURTHER 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 86 YR Required Intervention 7274 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD