BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2640067 · Received July 5, 2012

    Report

    Report Number
    3004209178-2012-05212
    Event Type
    Injury
    Date Received
    July 5, 2012
    Report Date
    June 7, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748251 LOT# SERIAL# (B)(4) IMPLANTED: 2006-(B)(6) EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 748251 LOT# SERIAL# (B)(4) IMPLANTED: 2006-(B)(6) EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 3389-40 LOT# V001582 SERIAL# IM PLANTED: 2006-(B)(6) EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 3389-40 LOT# V000631 SERIAL# IMPLANTED: 2006-(B)(6) EXPLANTED: PRODUCT TYP LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEARING LOSS. IT WAS UNCLEAR IF THIS WAS RELATED TO THE IMPLANTABLE NEUROSTIMULATOR (INS). ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention