BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3499697 · Received December 4, 2013

    Report

    Report Number
    3004209178-2013-21914
    Event Type
    Malfunction
    Date Received
    December 4, 2013
    Report Date
    November 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3389S-40, LOT# V050295, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 64002, LOT# N211843, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. 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 A PATIENT WAS SEEING A POWER-ON-RESET (POR) ON HER PROGRAMMER. IT WAS STATED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE POR HAD JUST APPEARED ON THE DAY OF THE REPORT. THE PATIENT "KEPT GETTING THE POOR COMMUNICATION SCREEN" AND IT WOULD GO BACK TO THE INFORMATION POR MESSAGE. WHEN THE PATIENT TRIED CLEARING THE POR THEY SAW THE POOR COMMUNICATION SCREEN. IT WAS STATED THAT THE PATIENT FELT AS THOUGH HER IMPLANTABLE NEUROSTIMULATOR (INS) HAS SHIFT UP TOWARDS HER CLAVICLE. IT WAS STATED THAT THE INS HAD BEEN LIKE FOR "SEVERAL MONTHS". THE PATIENT WAS UNABLE TO GET COMMUNICATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HER DEVICE OR THERAPY. THE PATIENT HAD THE DEVICE RESET AND THE CONTROLLER HAD WORKED EVER SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628171 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR