BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1150404 · Received September 5, 2008

    Report

    Report Number
    3004209178-2008-05519
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 6, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. HE ALSO EXPERIENCED INCREASED RIGIDITY, BALANCE ISSUES, AND FAINTING SPELLS. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE STATUS LIGHTS ON PATIENT PROGRAMMER WERE ASSESSED AND THE REPORTER CONFIRMED THAT THE NEUROSTIMULATOR LIGHT AND "STIM ON" LIGHT WERE LIT. THE REPORTER WAS REDIRECTED TO THE PATIENT'S HEALTH PROVIDER. ADDITIONAL INFORMATION 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 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R LEAD MODEL 3387 LOT# J0451702V IMPLANTED| EXTENSION MODEL 7482 LOT# NHU088009V IMPLANTED| PROGRAMMER MODEL UNK LOT# UNKNOWN| EXPLANTED| EXPLANTED