BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 3863587 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11266
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 22, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT # V245964, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V 245964, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 7482A40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NEEDED A MAGNETIC RESONANCE IMAGE (MRI). IT WAS NOTED THE DOCTOR CHECKED THE IMPEDANCES AND ONE SIDE READ 64 OHMS AND THE CURRENT WAS 522. IT WAS STATED THE DOCTOR COULD NOT RUN THE IMPEDANCES HIGHER AS THE PATIENT FELT SHOCKING WHEN THE IMPEDANCES WERE RUN. IT WAS STATED NO MRI WAS PERFORMED. IT WAS FURTHER REPORTED THE PATIENT HAD A COMPUTERIZED TOMOGRAPHY (CT) SCAN INSTEAD OF THE MRI. IT WAS NOTED THERE WERE NO ISSUES AND THE PATIENT HAD A SCHEDULED FOLLOW-UP WITH THEIR SURGEON FOR THE WEEK FOLLOWING REPORT ABOUT POSSIBLE BACK SURGERY. IT WAS NOTED THE PATIENT WAS DOING FINE WITH NO PROBLEMS WITH THE THERAPY AND DEEP BRAIN STIMULATOR (DBS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337810 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1