BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1990761 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02124
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    October 15, 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
    GA, 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 DISTAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE INNER TUBING WAS KINKED/BUCKLED, THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVEHEAD, THERE WAS A TIP SEAL OBSERVATION AND THE LEAD WAS DAMAGED AT IMPLANT. THE ANALYST ALSO NOTED THAT THE LEAD WAS RETURNED WITH THE HELIX FULLY EXTENDED AND STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HELIX WOULD NOT DEPLOY. AFTER THE LEAD WAS REMOVED FROM THE PATIENT, IT TOOK OVER 40 TURNS BEFORE THE HELIX "POPPED" OUT. ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. 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 60 YR Other