BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3902298 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12264
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 9, 2014
    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
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, LOT# V568684, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3387S-40, LOT# V568684, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7438, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD A RETURN OF TREMORS IN HIS RIGHT ARM SINCE A HARD FALL ¿ON SATURDAY.¿ THE PATIENT¿S SISTER REPORTED THAT THEY WERE WORSE THAN THEY HAD EVER BEEN. THE PATIENT HAD ALSO BEEN HAVING HEADACHES SINCE THE FALL. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER). EIGHT DAYS LATER IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED, BUT THE REPORTER HAD NO INFORMATION ABOUT THE RESOLUTION OF THE REPORTED ISSUES. THE PATIENT TOLD THE REPORTER THAT HE HAD HIS OWN PHYSICIAN OUT OF TOWN WHO HE WOULD CONSULT WITH. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379379 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization