BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4107116 · Received September 22, 2014

    Report

    Report Number
    3004209178-2014-17474
    Event Type
    Injury
    Date Received
    September 22, 2014
    Report Date
    August 29, 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
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V093181, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3387S-40, LOT# V085139, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 64002, LOT# N312400, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALY. THE INS WAS AT NORMAL END OF LIFE AND THERE WAS NO TELEMETRY OR OUTPUT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REFERRED FOR AN MRI IN JUNE BY HER NEUROLOGIST AND THE MRI WAS DONE WITH A 3T MACHINE. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF DURING THE MRI AND WHEN THE PATIENT WAS FINISHED SHE TURNED ON THE INS AND THERE WAS AN END OF LIFE (EOL) MESSAGE ON THE SCREEN. IT WAS NOTED THAT THE PATIENT WAS TOLD BEFORE THE MRI WAS SCHEDULED THAT SHE HAD ABOUT ONE YEAR REMAINING ON THE INS. THERE WAS NO HARM DONE TO THE PATIENT EXCEPT THAT THE INS NEEDED TO BE REPLACED. THE PATIENT EXPERIENCED LESS THAN 50% THERAPY RELIEF. THE LOCATION OF ISSUE WAS ON THE RIGHT SIDE IMPLANT. THE NEUROSURGEON WANTED TESTING TO BE DONE TO DETERMINE IF THE MRI HAD DAMAGED THE INS SUCH THAT IT REQUIRED REPLACEMENT. THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. THE ACTION REQUIRED AS A RESULT OF THE EVENT WAS A REPLACEMENT. INFORMATION WAS RECEIVED FOUR DAYS LATER INDICATING THAT TH E INS WAS REPLACED, THE PATIENT WAS PROGRAMMED TO HER PRIOR SETTINGS AND WAS DOING FINE. IT WAS DOUBTED THAT THE INS WAS EVER ON CYCLING MODE. IT WAS NOTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587233 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1