BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1072301 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03590
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 1, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0067-007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. 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. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: PROXIMAL CONDUCTOR WAS FRACTURED; FULL LEAD WAS RETURNED FOR ANALSYSIS. IT WAS REPORTED THAT THERE WAS AN OUTER INSULATION BREACH. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED A SHOCK DUE TO NOISE. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN 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 INSULATION, HOLE(S) IN INTERFERENCE SHOCK, INAPPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN OUTER INSULATION BREACH. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED A SHOCK DUE TO NOISE. THE LEAD WAS EXPLANTED AND REPLACED. 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 Required Intervention 7279 IMPLANTABLE PACEMAKER/CARDIO/DEFIB