BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3315944 · Received August 29, 2013

    Report

    Report Number
    3004209178-2013-15378
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Report Date
    August 5, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387-40, LOT# V003964, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# V003823, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 64002, LOT# N221054, IMPLANTED: (B)(6), 2010, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SHOWING SOME "MORE SIGNS" OF SYMPTOM RETURN WHICH SEEMED WORSE WHEN THE PATIENT WAS AT HOME. THE REPORTER INDICATED THAT THERE WAS A HAM RADIO TOWER LOCATED 300 FEET FROM THE PATIENT'S HOUSE. THE PATIENT REPORTEDLY MOWED NEAR THIS RADIO TOWER WHICH PLACED HIM WITHIN 25 FEET FROM IT. THE PATIENT ONLY MOWED THAT SECTION PERIODICALLY. IT WAS NOTED THAT THE PATIENT WAS ALSO FALLING MORE OFTEN THAN BEFORE. THE REPORTER NOTED THAT THE HEALTH CARE PROFESSIONAL HAD RECENTLY INTERROGATED THE IMPLANTABLE NEUROSTIMULATOR (INS) AND SAW NO UNUSUAL ON/OFF ACTIVATIONS. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428210 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1