BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4200592 · Received October 24, 2014

    Report

    Report Number
    3004209178-2014-20375
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    September 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
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387-40, SERIAL # UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, SERIAL # UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 7482, # SERIAL # UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 7482, SERIAL # UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 64002, SERIAL # UNKNOWN, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ADAPTER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED OVERSTIMULATION AND SHOCKING AND JOLTING SENSATIONS. IT WAS ALSO NOTED THAT THE PATIENT HAD ¿ELECTRICAL SENSATIONS¿ AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE RELATED TO ¿OPTICAL SENSATIONS.¿ IMPEDANCE TESTING WAS PERFORMED AND FOUND LOW IMPEDANCES OF 59 OHMS. THE CAUSE OF THE ISSUE WAS NOT KNOWN AND THE ISSUE WAS NOT RESOLVED. THE PATIENT STATUS AT THE TIME OF REPORT WAS UNKNOWN. ADDITIONAL FOLLOW UP IS BEING PERFORMED TO OBTAIN THE PATIENT OUTCOME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT SURGERY WAS REQUIRED AS A RESULT OF THE IMPEDANCE ISSUES PREVIOUSLY REPORTED. INITIALLY, THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TESTED AND LOW IMPEDANCES, ALL BETWEEN 50 OHMS AND 70 OHMS, WERE MEASURED ON 3 POLES ON THE RIGHT ELECTRODE. THE LOW IMPEDANCES PERSISTED WHEN TESTING WAS PERFORMED ON THE ADAPTOR. AFTER CHANGING THE ADAPTOR, THE IMPEDANCES OF THOSE POLES WERE BETWEEN 819 OHMS AND 831 OHMS. THE INS WAS THEN CONNECTED, AND THE SAME LOW IMPEDANCES WERE OBSERVED ON THE ¿FIRST CANAL¿ (0-7). THE CANAL WAS CHANGED TO 8-15, AND A LOW IMPEDANCE OF 56 OHMS WAS MEASURED ON POLES 12 AND 15. AFTER OPENING THE ¿SAFETY CAP¿ WHILE CHECKING THE CONNECTION BETWEEN THE LEAD AND EXTENSION, IT WAS DISCOVERED THAT THERE WAS DAMAGE TO THE WIRE COATING ON BOTH LEADS, ABOVE THE CONNECTION POINT OF THE EXTENSION AND LEAD. THAT PORTION OF THE LEADS HAD NO WIRE COATING. ADDITIONALLY, THE WIRE COATING "ON THE MIDDLE OF ONE LEAD" WAS DAMAGED MY MECHANICAL REMOVAL. THIS WAS DETERMINED TO HAVE BEEN THE CAUSE OF THE IMPEDANCE ISSUE. AN ¿EMERGENCY¿ REPLACEMENT OF THE PATIENT¿S EXTENSIONS AND LEADS WERE REQUIRED ON THAT SAME DAY DUE TO THE ¿EXTREME DYSTONIA PROBLEMS¿ OF THE PATIENT WITHOUT STIMULATION. THE NEW LEADS/EXTENSIONS WERE THEN CONNECTED TO THE PATIENT¿S INS. IMPEDANCES WERE SUBSEQUENTLY OK AND THE ISSUE RESOLVED. X-RAYS WERE ALSO TAKEN, BUT THE RESULTS WERE NOT PROVIDED. AFTER THE PROCEDURE, THERAPY WAS SWITCHED ON AND THE PATIENT ¿FELT GOOD¿ IN THE OPERATING ROOM. IT WAS NOTED THAT THE PATIENT HAD BEEN PLACED IN THE INTENSIVE CARE UNIT FOR MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679134 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R