BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2965131 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01727
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT 5076 IMPLANTABLE PACING LEAD (B)(6) 2011 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 PHYSICIAN CONTACTED THE SALES REPRESENTATIVE (SR) TO STATE THAT DURING A CHANGEOUT, IT APPEARED THAT THE LEAD HAS "COIL EXTRUSION" WHEN LOOKING AT IT IN THE FLUORO VIEW. ALL IMPEDANCES AND MEASUREMENTS ARE NORMAL ACCORDING TO THE SR. FURTHER INVESTIGATION BY THE QUALITY ENGINEERS INDICATED THAT THE LEAD APPEARED TO BE INTACT AND THE "CONDUCTORS APPEAR TO REMAIN WITHIN THE DIAMETER OF THE LEAD BODY." 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
    67551 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR