BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3204412 · Received July 3, 2013

    Report

    Report Number
    3007566237-2013-01209
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), (B)(4).

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED IN MFG. REPORT # 6000030-2005-01413 THAT THE PUMP "TORE AWAY FROM MY SIDE...FROM WHEREVER THEY HAD STITCHED IT MAKING IT LOPSIDED SO THAT PART OF THE PUMP ACTUALLY STUCK OUT INSTEAD OF LAYING FLAT IN MY ABDOMEN." IT WAS NOTED THAT THE PUMP HAD BEEN LOPSIDED FOR "QUITE A WHILE." ANY SUBSEQUENT INFORMATION WILL NOW BE FOLLOWED UP UNDER THIS REPORT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305419 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1