BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4212971 · Received October 30, 2014

    Report

    Report Number
    3004209178-2014-20645
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389-40, LOT# J0349459V, IMPLANTED: 2004 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389-40, LOT# J0349459V; PRODUCT TYPE LEAD PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A ¿CALL YOUR DOCTOR¿ ICON AND AN OUT OF REGULATION (OOR) CONDITION ON THE PATIENT PROGRAMMER. THEY WERE UNABLE TO ADJUST STIMULATION. THE OOR HAD DISPLAYED WHEN A HEALTHCARE PROFESSIONAL HAD ATTEMPTED TO TURN STIMULATION OFF FOR THE RIGHT IMPLANTABLE NEUROSTIMULATOR (INS) PRIOR TO PATIENT¿S BLADDER SURGERY ON THE DATE OF THIS REPORT. THEY WERE UNABLE TO GET THE OOR MESSAGE TO GO AWAY AND A HEALTHCARE PROFESSIONAL CAME IN WITH A CLINICIAN PROGRAMMER TO TURN OFF THE INS FOR SURGERY. BOTH INS¿S WERE TURNED ON FOLLOWING SURGERY. A MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT ON (B)(6) 2014 TO CHECK THE RIGHT INS. ELEVATED IMPEDANCE WERE FOUND ON CONTACT 2; C/2-4001, 0/2-4613, 2/3-5748. ALL OTHER CONTRACTS WERE NORMAL. IMPEDANCES HAD BEEN CHECKED ON BOTH SIDES AND LEFT INS HAD NORMAL IMPEDANCES. PATIENT SETTINGS WERE 60PW, 185HZ, C+1- FOR BOTH SIDES AND RIGHT SIDE 2.5V AND LEFT SIDE 3.4V. EVERYTHING WAS NORMAL AND THERE WAS NO COMPLAINT OF ANY THERAPY OR DEVICE ISSUES AT THE APPOINTMENT ON (B)(6) 2014. THE PATIENT HAD NEVER SEEN THE OOR MESSAGE PRIOR TO (B)(6) 2014. THE CAUSE OF THE EVENT WAS NOT DETERMINED AS EVERYTHING LOOKED WITHIN NORMAL PARAMETERS ON STIMULATING CONTACTS. THERE WAS NO KNOWN CAUSE FOR HIGHER IMPEDANCES, NO LEADS WERE FRACTURED AND NO TROUBLESHOOTING WAS DONE OTHER THAN IMPEDANCE CHECKS. THE PATIENT SEEMED TO BE DOING FINE AND WAS RECEIVING THERAPY EFFEC TIVELY AS OF (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694981 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR