BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2553521 · Received April 30, 2012

    Report

    Report Number
    3004209178-2012-02793
    Event Type
    Injury
    Date Received
    April 30, 2012
    Report Date
    April 3, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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

    PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYP PROGRAMMER, PATIENT, PRODUCT ID: 37085-60 SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYP EXTENSION, PRODUCT I:D 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYP EXTENSION, PRODUCT ID: 3387S-40, LOT# V014191, IMPLANTED: (B)(6) 2006, PRODUCT TYP LEAD, PRODUCT ID: 3387S-40, LOT# V014191, IMPLANTED: (B)(6) 2006, PRODUCT TYP LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS REPLACED DUE TO NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED PRIOR TO THE DEVICE BEING REPLACED THE PATIENT HAD NOT HAD THERAPY FOR APPROXIMATELY 2 YEARS DUE TO INSURANCE ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention