BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1875143 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11634
    Event Type
    Injury
    Date Received
    October 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) HELIX DISENGAGED FROM HELICAL CHANNEL; FULL LEAD WAS RETURNED AND ANALYZED. BLOOD IN/ON HELIX/LOBE MECHANISM(SLEEVE HEAD). EVALUATION SUMMARY (B)(4) FULL LEAD.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN 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 75 YR Other 6947 IMPLANTABLE TACHY LEAD| D224VRC IMPLANTABLE PACEMAKER/CARDIO/DEFIB