BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3232354 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11912
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 338940, LOT# B0724824K, PRODUCT TYPE LEAD; PRODUCT ID 338940, LOT# B0724823K, PRODUCT TYPE LEAD; PRODUCT ID M924256A, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SEVERE INFECTION OF HER DEEP BRAIN SYSTEM. THE LEADS REMAINED WITHIN THE BRAIN AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE PATIENT HAD BEEN TREATED FOR 2 WEEKS AT THE TIME OF THE REPORT. THE PARKINSON¿S SYMPTOMS WERE BEING TREATED WITH MEDICATION, BUT THE CONDITION OF THE PATIENT WAS SIMILAR TO THE CONDITION PRIOR TO IMPLANT ¿ BEDRIDDEN, WEAKNESS, AND OCCASIONAL SPEAKING. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333970 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention