BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3965016 · Received July 29, 2014

    Report

    Report Number
    9614453-2014-01557
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    July 11, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REQUIRED RE-INTERVENTION DUE TO COMPLICATIONS. THE REPORTER STATED THAT THE ENTIRE SYSTEM WAS EXPLANTED DUE TO INFECTION IN (B)(6) 2010. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440828 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention