BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1162110 · Received September 16, 2008

    Report

    Report Number
    6000032-2008-05720
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    May 1, 2008
    Report Date
    August 14, 2008
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATION WAS IN THE WRONG LOCATION. THE PT HAD NOT HAD RELIEF FOR YEARS. THE RIGHT SIDE WAS WORKING BUT THE LEFT SIDE WAS NOT. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS EVENT. THE PT PROGRAMMER WAS REPLACED. THE PT HAD SURGERY; THE DEVICE SYSTEM WAS REPLACED. THE PT CONTINUES TO HAVE PROBLEMS. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW LGW MDT PUERTO RICO OPERATIONS CO, MED REL 7427V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| LEAD MODEL 3487A LOT# J0313860V IMPLANTED| EXPLANTED| EXTENSION MODEL 7495LZ LOT # NHK026799V IMPLANTED