BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2812230 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16170
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 18, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE R-WAVES WERE ACCEPTABLE THROUGH THE ANALYZER AND THE DEVICE POST-IMPLANT, HOWEVER THE NEXT DAY THE R-WAVES HAD DROPPED TO A LOW VALUE. THE LEAD WAS REPOSITIONED AND THE R-WAVES WERE ACCEPTABLE. THRESHOLD AND IMPEDANCE MEASUREMENTS WERE CONSISTENT. THE LEAD REMAINS IN USE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R