BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2250622 · Received September 9, 2011

    Report

    Report Number
    3007566237-2011-07640
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 22, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT'S DEVICE WAS EXPLANTED DUE TO AN INFECTION. A SWAB WAS TAKEN, BUT THE RESULTS WERE NOT KNOWN AT THE TIME OF THIS REPORT. IT WAS REPORTED THAT THERE WAS NO PT INJURY. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MEDTRONIC NEUROMODULATION 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention