BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3636837 · Received February 20, 2014

    Report

    Report Number
    3004209178-2014-03322
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Report Date
    January 30, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 64001, LOT# N242249, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. PRODUCT ID: 3389S-40, LOT# V479550, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 64001, LOT# N412086, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID; 3387-40, LOT# J0206376V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THERE WERE TELEMETRY ISSUES. IT WAS NOTED THAT AT 4 AM PATIENT WAS IN THE EMERGENCY ROOM FOR DYSTONIC TICS. THE RIGHT IMPLANTABLE NEUROSTIMULATOR (INS) WAS INTERROGATED WITH NO ISSUES AND WAS FINE VIA PATIENT PROGRAMMER. THE LEFT INS SHOWED DEVICE NOT SUPPORTED ICON VIA THE PATIENT PROGRAMMER. THE PATIENT HAD A RETURN OF SYMPTOMS. IT WAS FURTHER NOTED THAT ONLY THE PATIENT PROGRAMMER WAS AVAILABLE TO TROUBLESHOOT WITH. IT WAS NOTED THAT THE RETURN OF TICS HAD STARTED ABOUT AN HOUR PRIOR TO THIS REPORT. IT WAS NOTED THAT IF THE DEVICE WAS OFF THE PATIENT USUALLY KNEW AT ABOUT AN HOUR. PATIENT TYPICALLY RAN AT 2.9V. TICS HAD STARTED SUDDENLY. IT WAS LATER REPORTED THAT THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL. PATIENT HAD NO STIMULATION BEING DELIVERED. IT WAS LATER REPORTED AT THE APPOINTMENT ON (B)(6) 2014, THE PATIENT HAD THERAPY RESUMED. IT WAS NOTED THAT THEY WERE ABLE TO TAKE IMPEDANCES AND COMMUNICATE WITH THE IMPLANT. THERAPY HAD RESUMED THE (B)(6) BY TURNING THE IMPLANT BACK ON. IT WAS DETERMINED THE PATIENT WAS ATTEMPTING TO USE THE PREVIOUS PATIENT PROGRAMMER FROM PREVIOUS IMPLANT. A COMPATIBLE PATIENT PROGRAMMER WAS PROVIDED. IT WAS UNKNOWN WHY PATIENT LOST THERAPY. NO PROGRAMMING ADJUSTMENTS WERE MADE. PATIENT SEEMED TO BE DOING FINE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NEUROSTIMULATOR STATUS WAS OK AND THERE WERE NO ELECTRODES OUT OF RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108345 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00022 YR