BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2203278 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11852
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 10, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 NO ANOMALIES WERE FOUND. HOWEVER, THE DEFIBRILLATION COIL WAS DISTORTED. THE INNER TUBING WAS KINKED/BUCKLED. THE HELIX/LOBE WAS DISTORTED/BENT. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND SLEEVE HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THE PATIENT'S ANATOMY PRECLUDED THE LEAD FROM BEING IMPLANTED. ACCESS WAS EXTREMELY TIGHT AND THE COIL GOT STUCK AND WOULD NOT ADVANCE. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS 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 67 YR Other