BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4992471 · Received August 11, 2015

    Report

    Report Number
    3004209178-2015-15800
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 20, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V269090, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE CONSUMER THAT REPORTED WHEN THEY CHECKED THE PROGRAMMING, "IT SHOWED PROGRAM C BUT IT WON'T SHOW OK" AND THEY GOT A FLASHING TRIANGLE. IT APPEARED THAT THE PATIENT ACCIDENTALLY TURNED THE STIMULATION OFF. THE PATIENT WAS WALKED THROUGH ON HOW TO TURN THE STIMULATION BACK ON AND HOW TO CHANGE THE PROGRAMMER FORM SYMBOL MODE BACK TO LETTER MODE. THERE WAS NO RECENT EMI OR MEDICAL TEST EXPOSURE. THE PATIENT FELT PRETTY OFF AND WAS HAVING A HARD TIME WALKING. THEY BELIEVED IT HAD BEEN HAPPENING SINCE 8AM ON THE MORNING OF REPORT. IT WAS A SUDDEN CHANGE IN SYMPTOMS/THERAPY. THE PATIENT WAS IMPLANTED FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. FURTHER FOLLOW-UP IS BEING CONDUCTED TO DETERMINE IF TURNING THE INS'S BACK ON RESOLVED THE PATIENT'S SYMPTOMS. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT. **PLEASE SEE MANUFACTURER REPORT #3004209178-2015-15798 FOR INFORMATION ON THE PATIENT'S CONCOMITANT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525877 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR