BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2987370 · Received March 4, 2013

    Report

    Report Number
    3004209178-2013-03248
    Event Type
    Injury
    Date Received
    March 4, 2013
    Report Date
    February 8, 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
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3389S-40 LOT# V173198, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3389S-40 LOT# V173198, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BALANCE WAS WORSENING WHICH RESULTED IN MULTIPLE FALLS AFTER DEEP BRAIN STIMULATION PROGRAMMING. IT WAS NOTED THAT THE PATIENT'S BALANCE/GAIT CONTINUED TO WORSEN. IT WAS STATED THAT THE PATIENT WAS HOSPITALIZED TO STABILIZE BALANCE. IT WAS NOTED THAT THE PATIENT RECOVERED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91937 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization