BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4932922 · Received July 22, 2015

    Report

    Report Number
    3004209178-2015-13919
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    May 15, 2014
    Report Date
    May 19, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V191279, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V191279, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A BURNING SENSATION. IT WAS NOTED THAT THURSDAY PRIOR TO THE DATE OF THIS REPORT THE PATIENT WAS AT THE PHYSICAL THERAPIST DOING PUSH-UPS. PATIENT FELT A BURNING SENSATION AROUND THE IMPLANT. IT WAS FURTHER NOTED THAT THE PATIENT HAD INJURED HER BACK IN (B)(6) PRIOR TO THE DATE OF THIS REPORT AND WAS WORKING ON BALANCE SINCE FALLING. PATIENT'S DEVICE WAS REPLACED DUE TO NORMAL BATTERY DEPLETION IN (B)(6) PRIOR TO THE DATE OF THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477148 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR