BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 4788577 · Received May 21, 2015

    Report

    Report Number
    3004209178-2015-09536
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Date of Event
    April 1, 2015
    Report Date
    May 4, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 3387S-40, LOT# V113344, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V098699, 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 THAT THERE WERE TELEMETRY ISSUES AND A POWER ON RESET (POR) MESSAGE WAS DISPLAYED. THE POR OCCURRED WHEN THE HEALTHCARE PROFESSIONAL (HCP) INITIALLY INTERROGATED THE IMPLANTABLE NEUROSTIMULATOR (INS) USING THE CLINICIAN PROGRAMMER. THE HCP HAD NOT BEEN ABLE TO RE-INTERROGATE THE INS AND THEY COULD NOT REPRODUCE THE POR MESSAGE. THE CLINICIAN PROGRAMMER DISPLAYED NO COMMUNICATION. THE PATIENT PROGRAMMER JUST DISPLAYED THE LIGHTS FOR THE 9V BATTERY ICON. THE PATIENT¿S RIGHT SIDE WAS PROGRAMMED TO C+, 5- AT 4.4V, 60 USEC, AND 185 HZ AND THEIR LEFT SIDE WAS PROGRAMMED TO 0+, 1- AT 4.2V, 60 USEC, AND 185 HZ. A LONGEVITY CALCULATION USING 900 OHMS FOR THE THERAPY IMPEDANCE WAS ESTIMATED TO BE 35 MONTHS. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330992 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR