BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1201508 · Received October 17, 2008

    Report

    Report Number
    3004209178-2008-06640
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED DYSKINESIA. THE PATIENT WAS AT HOME AND TURNED OFF THE STIMULATOR AS INSTRUCTED BY THE HCP. THE PATIENT TOOK SOME MEDICATION AND DID NOT FEEL RIGHT AFTERWARD. IT WAS ALSO REPORTED THE PATIENT HAD A BAD FALL TWO TO THREE WEEKS PRIOR TO THE EVENT AND WAS CHECKED AT THE HOSPITAL. NO CHANGES WERE DETERMINED AT THAT TIME.

    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 Required Intervention IMPLANTED:| EXPLANTED:| EXTENSION MODLE 7482 LOT# NHU143630V| EXPLANTED:| IMPLANTED:| LEAD MODEL 3387 LOT# V014846