BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3222559 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11658
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 25, 2013
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3387S-40, LOT# V063296, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V063296, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, 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 LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAS BEEN HAVING RADIATION TREATMENT, FOR THE PAST MONTH, FOR SQUAMOUS CELLS ON THE FRONT OF HIS FOREHEAD AND BACK/TOP AREA OF HIS HEAD 3 TIMES WEEKLY. RADIATION WAS ENDING ON (B)(6) 2013 AND THE HEALTH CARE PROFESSIONAL (HCP) STATED THE RADIATION SHOULD NOT AFFECT THE DEEP BRAIN STIMULATOR (DBS) SYSTEM. THE LEADS WERE ABOUT MIDWAY TO EXPOSURE OF THE RADIATION. HIS TREMORS HAD INCREASED FOR THE PAST TWO WEEKS PRIOR TO THIS REPORT AT ABOUT 2PM. THE TREMORS WOULD NOT DECREASE EVEN AFTER HE TOOK SINEMET (LEVODOPA CARBIDOPA) THREE TIMES A DAY. HE TOOK TWO PILLS TWICE DAILY. ABOUT 2.5 WEEKS PRIOR TO THE REPORT HIS BALANCE GOT WORSE. HE WAS LEANING LEFT AND THE TREMORS INCREASED TO WHERE HE FELL OFF HIS BIKE. HE GOT SCRAPPED UP FROM THE FALL BUT DID NOT FALL ON HIS HEAD. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT THE WEEK OF THIS REPORT. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322976 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR