BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3122937 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-08013
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    May 3, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387S-40 LOT# V964030, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3387S-40 LOT# V964030, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: NEU_LEAD CAP_ACC LOT# SERIAL# UNKNOWN, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A STROKE FOUR DAYS AFTER HAVING THE DEVICE "INSTALLED." IT WAS NOTED THAT THE PATIENT STILL SUFFERED FROM THE STROKE ONE YEAR AFTER THE IMPLANTED DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER REPORTED THE PATIENT DOES NOT SPEAK QUICKLY DUE TO A STROKE THEY HAD LAST YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223660 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Other