BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1193429 · Received October 7, 2008

    Report

    Report Number
    6000032-2008-06376
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 11, 2008
    Manufacturer
    MDT PEURTO RICO OPERATION CO., MD REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED INTERMITTENT STIMULATION AND STIMULATION IN THE WRONG LOCATION. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. THE PATIENT HAD LOST A SIGNIFICANT AMOUNT OF WEIGHT. THE PATIENT'S SYMPTOMS WERE LOCATED AT THE PARESTHESIA AREA. THE LEAD WAS LOCATED IN THE CERVICAL REGION FOR THE TREATMENT OF ARM PAIN. PALPATING AT THE LEAD/EXTENSION JUNCTION CAUSED THE STIMULATION TO CHANGE. THE PATIENT'S DEVICE WAS REPROGRAMMED AND THE PATIENT HAD ADEQUATE COVERAGE. HE STATED THAT THE INTERMITTENT STIMULATION WAS TOLERABLE. THE PATIENT DECIDED HE WOULD WAIT AND TRY OUT THE NEW PROGRAMMING BEFORE PURSUING OTHER OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MDT PEURTO RICO OPERATION CO., MD REL 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention EXPLANTED:| LEAD: MODEL 3986A| EXTENSION: MODEL 7489| EXPLANTED:| PROGRAMMER: MODEL 7435