BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 3253086 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12456
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V269090, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3387S-40, LOT# V141264, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# V069269, IMPLANTED: (B)(6) 2008, 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) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE IMPEDANCES GREATER THAN 4,000 OHMS. IT WAS NOTED THAT "C3" WAS GREATER THAN 4000 OHMS. IT WAS STATED THAT AN "MRI WAS DUE TO LEAD POSITIONING PER TECHNICIAN". IT WAS NOT CLEAR WHAT THAT MEANT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MRI SCAN WAS NOT PERFORMED. THERE WAS NO FURTHER DIAGNOSTIC TESTS PERFORMED, AND NO CAUSE OF ISSUE WAS DETERMINED AND NO INTERVENTIONS WERE TAKEN. IT WAS UNKNOWN IF THE PATIENT WAS RECEIVING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352931 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR