BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1172114 · Received September 18, 2008

    Report

    Report Number
    3004209178-2008-05894
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 19, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED INCREASED TREMOR FOLLOWING A FALL. DEVICE TROUBLESHOOTING SHOWED THE BATTERIES OF THE PROGRAMMER WERE OK. THE DEEP BRAIN STIMULATOR WAS ON. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR EXPLANTED:| EXTENSION: MODEL 7495-51| IMPLANTED:| LEAD: MODEL 3387| EXPLANTED: