BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3180697 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10663
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 3387-40, LOT# J0206635V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT# J0206635V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN E. COLI INFECTION THAT WAS LOCATED AT THE ¿SITE TO EAR.¿ IT WAS NOTED THAT THE INFECTION WAS ¿NOT INSIDE THE BRAIN, BUT UP TO THE EAR.¿ IT WAS FURTHER NOTED THAT THE BATTERY AND EXTENSION WERE REMOVED. IT WAS NOTED THAT INITIALLY, THE REPORTER STATED THAT THEY REMOVED THE LEAD BUT THEN STATED THAT ¿THEY DID NOT PULL THE BRAIN LEAD.¿ THE REPORTER THEN STATED ¿THEY REIMPLANTED AT THE SAME TIME THEY TOOK IT OUT.¿ IT WAS UNCLEAR WHEN THE SYSTEM COMPONENTS WERE EXPLANTED. IT WAS NOTED THAT THE INFECTION RESOLVED AND THAT THE PATIENT WAS RECEIVING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280592 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention