BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3252862 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12440
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    November 7, 2012
    Report Date
    July 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT OR PRODUCT PROBLEM: HIP FRACTURE. CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387S-40, LOT# V335185, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V335517, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE ¿THERAPY DID NOT SEEM TO BE WORKING¿ FOR THE PATIENT AND THAT THE PATIENT ¿FELL AND BROKE HER HIP¿ ON (B)(6) 2012. IT WAS NOTED THE PATIENT WAS IN A WHEEL CHAIR AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: PLEASE SEE MFR. REPORT # 3004209178-2013-12438 FOR INFORMATION ON THE PATIENT¿S OTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352345 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other