BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2767405 · Received October 1, 2012

    Report

    Report Number
    3004209178-2012-08741
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Report Date
    September 4, 2012
    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
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3387S-40, LOT# V015148, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V014246, IMPLANTED: (B)(6) 2007,: PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PERFORMING AN ELECTROCARDIOGRAPHY, THERE WAS ARTIFACT FROM THE IMPLANTABLE NEUROSTIMULATOR (INS). PATIENT HAD SHOCKING OR JOLTING SENSATION. PATIENT REFUSED TO TAKE A PATIENT PROGRAMMER BECAUSE PATIENT GOT A JOLT WHEN TURNING THE DEVICE OFF AND BACK ON.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1