BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INS 37612 ACTIVARC MVD

    MDR report key: 4564962 · Received March 3, 2015

    Report

    Report Number
    3007566237-2015-00505
    Event Type
    Malfunction
    Date Received
    March 3, 2015
    Report Date
    February 10, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# V014246, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 64002, LOT# N318565, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER; PRODUCT ID 3387S-40, LOT# V014246, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE EXTENSION, PRODUCT ID NEU _UNKNOWN_LEAD, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE WAS AN ERROR CODE WITH THE DESCRIPTION OF 0X400. IT WAS REVIEWED THAT THERE WAS A PARITY ERROR. IT WAS UNKNOWN IF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS OFF DURING THE SESSION. IT WAS UNKNOWN IF A CT OR OTHER RADIATION SOURCES WAS THE CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POWER ON RESET (POR) CONDITION. THE ERROR CODE WAS 0400. AFTER THE PATIENT LEFT THE CLINIC THEY LOOKED AT THE PHYSICIAN PROGRAMMER PROGRAMMING STRIP AND REALIZED THAT THE STIMULATION WAS SILL OFF WHEN THE PATIENT LEFT THE CLINIC. THE PATIENT HAD NOT TURNED STIMULATION BACK ON SINCE THE PATIENT WAS BACK AGAIN. THE STIMULATION WAS OFF GOING INTO THE PHYSICIAN PROGRAMMER SESSION. THE HEALTHCARE PROFESSIONAL (HCP) WAS WALKED THROUGH TURNING THE STIMULATOR BACK ON, WHICH WAS DONE SUCCESSFULLY. THE PATIENT WAS AN EPILEPSY PATIENT SO THE PATIENT COULD NOT FEEL STIMULATION AND DID NOT SENSE BENEFIT LIKE OTHER DEEP BRAIN STIMULATION (DBS) PATIENT BEING TREATED FOR DIFFERENT INDICATIONS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE 0X400 CODE WAS PRESENT UPON THE FIRST INTERROGATION BUT THE SECOND SEEMED OKAY. THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. THE PATIENT WAS DOING FINE AND RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146122 INS 37612 ACTIVARC MVD STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1