BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1922522 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12985
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 17, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 WAS RETURNED, ANALYZED AND THE HELIX WAS FOUND TO BE DISENGAGED FROM THE HELICAL CHANNEL. IT WAS ALSO NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD ON THE SLEEVE HEAD, AND IN/ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE HELIX ON THE LEAD WOULD NOT EXTEND. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other