BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1013829 · Received March 14, 2008

    Report

    Report Number
    3004209178-2008-01261
    Event Type
    Injury
    Date Received
    March 14, 2008
    Report Date
    February 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED THAT SINCE THE STIMULATOR WAS REPROGRAMMED, SHE EXPERIENCED A CONSTANT JOLTING SENSATION EVEN WHEN THE STIMULATION WAS DECREASED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PORGRAMMER MODEL 7435| EXPLANTED| LEAD MODEL 3890| EXPLANTED| IMPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| EXTENSION MODEL 7489| EXPLANTED| LEAD MODEL 3890| EXTENSION MODEL 7489| EXPLANTED