BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1862844 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10528
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    July 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: (B)(4) : THE FULL LEAD, IN SEGMENTS, WAS RETURNED AND ANALYZED. THE HELIX WAS DISENGAGED FROM THE HELICAL CHANNEL; THE HELIX WILL NOT EXTEND DUE TO BEING OVER RETRACTED. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR AND ON THE OUTER TUBING OVERLAY. THE OUTER TUBING OVERLAY WAS BREACHED CUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HELIX COULD NOT BE EXTENDED AFTER SEVERAL SUCCESSFUL EXTENSIONS AND RETRACTIONS. THE LEAD WAS NOT USED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    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 68 YR Required Intervention