BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1061610 · Received June 17, 2008

    Report

    Report Number
    3004209178-2008-03273
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    June 1, 2008
    Report Date
    May 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE "DIDN'T WORK HALF THE TIME", WAS DIFFICULT TO ADJUST, AND CAUSED THE PT DISCOMFORT. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR IMPLANTED| EXTENSION: MODEL 7471 LOT#NHJ004810N| PROGRAMMER: 7435| LEAD: MODEL 3898 LOT#LB4502| IMPLANTED| EXPLANTED| EXPLANTED