BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3071713 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05209
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO IMPLANT, THE LEAD TIP WAS NOTED TO HAVE A SLIGHT BEND. BECAUSE, THIS WAS THE FIRST TIME IT HAD BEEN NOTED, THERE WAS NO REAL CONCERN. THE LEAD WAS IMPLANTED WITHOUT DIFFICULTY AND THERE WERE NO PERFORMANCE ISSUES. IT WAS NOTED THAT THERE IS CONCERN ABOUT THE PACKAGING OF THIS PRODUCT. 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
    172689 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR