BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3230258 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-11864
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT# V324755, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V323742, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL AROUND (B)(6) AND FRACTURED HER ARM, ALSO DAMAGING HER RADIAL NERVE. IT WAS NOTED THAT WHILE THE DBS DID HELP WITH THE PATIENT'S PARKINSON¿S SYMPTOMS, SHE STILL EXPERIENCED SOME RIGIDITY AND TONE SYMPTOMS AND DIFFICULTY WALKING. IN THE CASE OF THE FALL, THE PATIENT FROZE AND WAS UNABLE TO CATCH HERSELF BEFORE FALLING. IT WAS NOTED THAT THE FALL WAS NOT RELATED TO THE PATIENT¿S IMPLANT. 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
    329842 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention