BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3182658 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10714
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 1, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37092, LOT# 249360003, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: ACCESSORY: PRODUCT ID 37651, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3389-40, LOT# V006181, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 3389-40, LOT# V006181, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 64002, LOT# N215028, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: ADAPTER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FOCAL SEIZURE FOLLOWING A KNEE REPLACEMENT SURGERY IN 2011. IT WAS NOTED THE PATIENT WAS WONDERING IF HER DEVICE WAS DAMAGED FROM THE KNEE SURGERY. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT THEY WERE WORKING WITH THEIR DOCTOR OR MEDTRONIC REPRESENTATIVE.AN APPOINTMENT WAS SCHEDULED FOR (B)(6)-2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282584 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Other