BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1072062 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03840
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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. EVALUATION SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED, WITH NO ELECTRICAL ISSUES FOUND. THERE WAS BLOOD IN THE DISTAL CONDUCTOR. ALSO, THERE IS ONLY ONE SET OF SETSCREW MARKS ON THE IS-1 PIN, AND IT IS TOO PROXIMAL, INDICATING THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE. THE ANALYST NOTED THIS COULD HAVE CAUSED THE REPORTED ELECTRICAL ISSUES. THE BLOOD IN THE DISTAL CONDUCTOR MOST LIKELY ENTERED THROUGH THE IS-1 PIN AS NO INSULATION BREACHES WERE OBSERVED. THIS CAUSED THE HELIX TO NOT FUNCTION PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention