BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1181758 · Received September 30, 2008

    Report

    Report Number
    3004209178-2008-06220
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 4, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT SAID SHE HAD NOT SEEN A PHYSICIAN OR HAD HE DEVICE REPROGRAMMED SINCE IMPLANT IN 2005. SHE STATED A CT SCAN WAS DONE (DATE NOT REPORTED) AT A CLINIC CLOSER TO HER HOME AND SHOWED THE LEAD HAD MIGRATED. THE PATIENT'S STATUS WAS REPORTED TO BE "FAIR". ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 80 YR Required Intervention EXPLANTED:| EXPLANTED:| LEAD: MODEL 3487A| EXPLANTED:| EXTENSION: MODEL 7495-25| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7434-E| PROGRAMMER: MODEL 7435| EXPLANTED:| LEAD: MODEL 3998CWS| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7425| EXTENSION: MODEL 7489| NAT136796H| EXTENSION: MODEL 7489