BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1924151 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13430
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 17, 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
    MI, 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 IN SEGMENTS AND ANALYZED. THE HELIX WAS DISENGAGED FROM HELICAL CHANNEL. THERE IS BLOOD/BODY FLUID IN THE DISTAL CONDUCTOR (NOT OBSTRUCTED), ON THE OUTER TUBING OVERLAY, IN/ON THE HELIX/LOBE MECHANISM AND HELIX/LOBE MECHANISM (SLEEVE HEAD). TIP SEAL OBSERVATION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER REPOSITIONING THE LEAD, THE HELIX WOULD NOT EXTEND, EVEN AFTER MULTIPLE TURNS WERE PERFORMED. THE LEAD WAS NOT IMPLANTED. A NEW LEAD WAS USED. 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 73 YR Other