BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2982035 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03134
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 2, 2009
    Report Date
    February 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARED THAT THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE INDICATION DEVICE WAS USED FOR WAS LGW. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION: PRODUCT ID 3550-09, LOT# N177550, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2009. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3387-40, LOT# L70665, IMPLANTED: (B)(6) 2000, EXPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SURGICAL REVISION PERFORMED ON THEIR IMPLANTABLE NEUROSTIMULATOR (INS) DUE TO UNRELIEVED PAIN. SPECIFICALLY, THE RIGHT LEAD WAS REPLACED AND AN ADDITIONAL EXTENSION WAS IMPLANTED. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY BUT IT WAS INDICATED THAT THE PATIENT'S HEALTHCARE PROFESSION HAD NOT SEEN THE PATIENT SINCE THE SURGICAL PROCEDURE ON FEB 2, 2009. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88445 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Hospitalization| R