BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2913626 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00521
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V779188, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V779188, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PROGRAMMER WAS SHOWING "CALL YOUR DOCTOR" ICON AND HAD AN OUT OF REGULATION (OOR) CONDITION. CLINICIAN PROGRAMMER WAS REPORTED TO FUNCTION "FINE AND NORMAL." UPPER AND LOWER IMPEDANCE LIMITS WEREN'T SHOWING UP ON THE CLINICIAN PROGRAMMER. BATTERY VOLTAGE WAS REPORTED TO BE 2.96V AND WAS USED 93% OF TIME. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ACCIDENTALLY TURNED OFF FOR ABOUT THREE DAYS. THE IMPEDANCES WERE DESCRIBED AS SATISFACTORY AND ALL NORMAL. THERAPY PARAMETERS WERE 3.2V, 60US, 90HZ, C+, 1- 1497 OHMS, 3.1UA FOR STN1 AND 3.2V, 60US, 90HZ, C+, 2-, WITH UNKNOWN THERAPY IMPEDANCE FOR STN2. THERE WAS NO REPORTED LOSS OF THERAPY OR DIMINISHED THERAPY. THE PATIENT HAD BEEN SEEING THIS FOR ABOUT 1 MONTH AT THAT POINT. IT WAS ALSO REPORTED ELECTRODE IMPEDANCE TEST AT DEFAULT SETTINGS SHOWED VARIATION IN IMPEDANCE VALUES BETWEEN 1172 AND 3166 OHMS. WHEN DOING 3V TEST, THE OOR MESSAGE ON THE CLINICIAN PROGRAMMER AND THE FOLLOWING VALUES WERE DISPLAYED: C-0: 1352 OHMS; C-1: 1161 OHMS; C-2: 1194 OHMS; C-3: 1415 OHMS; 0-1: 1859 OHMS; 0-2: 2222 OHMS; 0-3: 2574 OHMS; 1-2: 1644 OHMS; 1-3: 2118 OHMS; 2-3: 1535 OHMS. THERAPY RESULTS FOR RIGHT STIMULATOR WERE STN1 1102 OHMS, STN2 1591 OHMS. NO RESULTS WERE REPORTED FOR THE LEFT STIMULATOR. IMPEDANCE TEST WITH PALPATION AND HEAD TURN SHOWED IMPEDANCE RANGE BETWEEN 1161 OHMS AND 2574 OHMS FOR ALL VALUES. AFTER ALL TROUBLESHOOTING, THE REASON FOR OOR WAS UNCLEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INFORMATION ALSO REPORTED ON PATIENT'S OTHER INS IN REGULATORY REPORT # 3004209178-2013-00518.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21009 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1