BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 3203169 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11218
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 10, 2013
    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
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT# V098699, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V010369, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT GOT A SHOCKING SENSATION EVERY TIME THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED ON OR OFF. THE REPORTER STATED THAT WHEN THE EVENT OCCURRED WAS UNKNOWN AND IT WAS "ROUTINE" FOR THE PATIENT. ADDITIONAL INFORMATION REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN AND THERE WERE NO ABNORMAL IMPEDANCE MEASURED. IT WAS NOTED THE EVENT OCCURRED WHEN THE DEVICE WAS INTERROGATED. IT WAS FURTHER NOTED THE PATIENT OUTCOME WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302368 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1