BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3895173 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-12050
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 5, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A GRADUAL RETURN OF SOME OF HER PARKINSON¿S DISEASE ASSOCIATED SYMPTOMS. IT WAS STATED THESE SYMPTOMS HAD RETURNED SINCE THE PATIENT HAD FALLEN OUT OF HER BED TWO WEEKS PRIOR TO REPORT. IT WAS NOTED THAT ¿THIS HAD HAPPENED BEFORE¿ AND THAT IT WAS ¿SUSPECTED THAT THERE WAS A BATTERY ISSUE.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    PLEASE NOTE THAT MANUFACTURER REPORT #3007566237-2014-01868 WAS FOUND TO HAVE ALSO REPORTED THE EVENT INFORMATION PREVIOUSLY FILED THROUGH THIS REPORT. ALL FURTHER REPORTS REGARDING THIS EVENT WILL BE FILED AS PART OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371664 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1