BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 2944332 · Received February 5, 2013

    Report

    Report Number
    9614453-2013-00033
    Event Type
    Death
    Date Received
    February 5, 2013
    Date of Event
    September 3, 2012
    Report Date
    January 16, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7428, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7482-51, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482-51, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 64002, SERIAL# (B)(4), PRODUCT TYPE: ADAPTER. PRODUCT ID: 3389-40, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 3389-28, SERIAL# (B)(4), PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT SAME LEADS AND EXTENSIONS WERE USED WITH THIS DEVICE AND THE PREVIOUS DEVICE (SERIAL NUMBER (B)(4)) THAT WAS USED AS AN EXTERNAL NEUROSTIMULATOR. A POCKET ADAPTER WAS ADDITIONALLY USED WITH THIS DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DIED FROM ASPIRATION.

    Description of Event or Problem · 1

    THIS EVENT HAS ALREADY BEEN REPORTED IN MANUFACTURER REPORT # 9614453-2012-00053. THE FOLLOWING INFORMATION WAS REPORTED: ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS RE-IMPLANTED ON (B)(6)-2012. THE PATIENT DEVELOPED AN INFECTION, AND THE DOCTOR REMOVED THE DEVICE ON (B)(6)-2012. THE REPORTER STATED THAT THE PATIENT DIED ON (B)(6)-2012, AND THE CAUSE OF THE EVENT WAS UNKNOWN. NO FURTHER INFORMATION WAS REPORTED. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT WILL BE REPORTED IN THIS MANUFACTURER REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48667 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Death| R