BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3936108 · Received July 15, 2014

    Report

    Report Number
    3004209178-2014-13042
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# VA023L5, IMPLANTED:(B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# VA08KLM, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A STIMULATION/THERAPY ISSUE, PATIENT WAS COMPLAINING OF SUDDEN SPEECH SLURRING. THE ACTION REQUIRED AS A RESULT OF THE EVENT WAS REPROGRAMMING AND HOSPITALIZATION. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED BUT WOULD BE IN THE FUTURE. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED OR IF THE CAUSE OF THE ISSUE WAS DETERMINED. PATIENT HAD A SUDDEN INCREASE IN SLURRING OF THEIR SPEECH AND HAD GONE TO THE HOSPITAL. THE HOSPITAL TESTS HAD COME BACK NEGATIVE. PATIENT¿S HUSBAND WANTED TO LOWER STIMULATION AND LOWERED BOTH SIDES BY ABOUT 1 VOLT, THE PATIENT HAD TOLERATED THIS WELL. TWO HOURS AFTER THE CHANGE THE PATIENT WAS DOING FINE AND HAD BEEN RELEASED FROM THE HOSPITAL. A FOLLOW-UP VISIT WAS BEING SCHEDULED TO CHECK IMPEDANCES AND REPROGRAM IF NECESSARY. THE PATIENT WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413744 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization