BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2925153 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00821
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    November 30, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3387-40 LOT# J0417811V, IMPLANTED: 2004 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PREVIOUSLY REPORTED CONCLUSION CODES NO LONGER APPLY TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED ¿ANXIETY WAS SETTING IN¿ FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S RIGHT BATTERY SPONTANEOUSLY TURNED ITSELF OFF WHEN THE PATIENT WENT THROUGH A SECURITY SYSTEM AT A LIBRARY. THE REPORTER NOTED THIS WAS "NOT SURPRISING." IT WAS REPORTED THAT THE PATIENT COULD BE IN "A BIT OF A MESS OF THIS WERE TO HAPPEN IN THE WRONG CIRCUMSTANCES," SUCH AS DRIVING, WHICH THE PATIENT TRIED TO AVOID "AS MUCH AS POSSIBLE." IT WAS REPORTED THAT A DOCTOR AND MANUFACTURER REPRESENTATIVE HAD SEEN THE PATIENT ONCE AND WOULD "CONTINUE TO FOLLOW." A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29244 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other