BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3202080 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11192
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V113842, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT THERAPY NEVER WORKED, AND SINCE THE LEAD WAS REVISED IN (B)(6) 2012, IT WAS GETTING EVEN WORSE. IT WAS INDICATED THAT PATIENT HAD DYSKINESIA AND ¿TOTALLY PARKINSON¿. IT WAS ADDED THAT PATIENT WAS TAKING SINEMET EVERY HOUR AND THE SYMPTOMS WOULD RETURN WHEN THE MEDICINE WORE OFF .IT WAS REPORTED THAT PATIENT HAS BAD PARKINSON DISEASE (PD) , DYSTONIA AND RETURNED OF SYMPTOMS THAT PATIENT HAD BEFORE THE SURGERY AT THE BEGINNING. THE PATIENT'S STATUS WAS REPORTED AS UNKNOWN AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300722 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention