BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3953353 · Received July 23, 2014

    Report

    Report Number
    9614453-2014-01551
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    March 12, 2014
    Report Date
    June 2, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748266, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 748266, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_STIMLOC_ACC, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_SILICONEANCHOR, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_SILICONEANCHOR, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A ¿RECURRENT INFECTION.¿ IT WAS STATED THERE WAS ¿NO¿ PATIENT INJURY OR DEATH AT THE TIME OF INITIAL REPORT. IT WAS NOTED THE PATIENT¿S DEVICE SYSTEM HAD BEEN EXPLANTED AT THE TIME OF INITIAL REPORT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431493 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention