BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3761230 · Received April 21, 2014

    Report

    Report Number
    3004209178-2014-07554
    Event Type
    Injury
    Date Received
    April 21, 2014
    Report Date
    April 1, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    H050003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3391S-40, LOT# V597842, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3391S-40, LOT# VA0886E, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE CAUSE OF THE EVENT WAS TREATMENT-EMERGENT HYPOMANIA. IT WAS NOTED THERE WAS NO DEVICE FAILURE. INTERVENTION INCLUDED ADDING DEPAKOTE. THE PATIENT WAS RELEASED TWO NIGHTS LATER FROM THE HOSPITAL. REFER TO MFR REPORT # 3004209178-2014-07553 FOR THE PATIENT'S DEVICE IMPLANTED ON THE OTHER SIDE

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR BEHAVIOR RELATED TO HYPOMANIA ON THE DATE OF THIS REPORT. IT WAS SUSPECTED THIS WAS DEVICE RELATED. IT WAS NOTED NO PROGRAMMING HAD BEEN DONE AT THIS TIME. ADDITIONAL INFORMATION RECEIVED THE NEXT DAY REPORTED THE PATIENT WAS HOSPITALIZED ON A VOLUNTARY BASIS FOR AGITATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE. REFER TO MFR REPORT # 3004209178-2014-07553 FOR THE PATIENT'S DEVICE IMPLANTED ON THE OTHER SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240937 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Hospitalization