BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2203603 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12588
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 21, 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
    TX, 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 AND ANALYZED. ANALYSIS DETERMINED THE HELIX DISENGAGED FROM HELICAL CHANNEL. IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS DISTORTED. BLOOD WAS OBSERVED IN/ON THE HELIX/LOBE MECHANISM, AND THERE WAS A TIP SEAL OBSERVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE LEAD HELIX WOULD NOT EXTEND OR RETRACT ON THE SECOND REPOSITION ATTEMPT. POSITIONING AND FIXATION DIFFICULTY OF THE LEAD WAS NOTED. A NEW LEAD WAS USED TO COMPLETE THE PROCEDURE. 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 73 YR Other