BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3088009 · Received May 1, 2013

    Report

    Report Number
    3007566237-2013-01498
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V163388, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387-40, LOT# J0455472V, IMPLANTED: (B)(6) 2005. PRODUCT TYPE: LEAD: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ELECTIVE REPLACEMENT INDICATOR (ERI) SEEN. IT WAS STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED ABOUT 2-3 MONTHS PRIOR TO THE REPORT. DURING THE IMPLANT SURGERY, THE OLD EXTENSION AND INS WERE REPLACED. DURING A PROGRAMMING SESSION ON THE DAY OF THE REPORT, IT WAS NOTED THAT ERI OCCURRED, HOWEVER, THE VOLTAGE WAS AT 2.895 V. THE IMPEDANCES WERE TESTED AT 0.7 V AND WERE "EITHER HIGH OR OUT OF RANGE." AT 1.5 V STILL THE IMPEDANCES WERE "HIGHER AND OUT OF RANGE" SO THE TEST WAS RUN AGAIN AT 3 V WITH RESULTS AS FOLLOWS: C-0=625 OHMS, C-1=743 OHMS, C-2=749 OHMS, C-3=793 OHMS. IT WAS STATED THAT "THE ONLY ONE OUT OF RANGE WAS THE BIPOLAR COMBINATION OF ZERO AND ONE, WHICH REPORTED AN IMPEDANCE OF 34 OHMS. THERAPY SETTINGS WERE C+, 1-, 0-, 120 US FOR PULSE WIDTH, 185 HZ, 3.2 V, 528 OHMS. IT WAS STATED THAT DURING THE IMPLANT PROCEDURE THE SCREWS WERE TIGHTENED WITH THE TORQUE WRENCH AND IMPEDANCES OF 40000 OHMS WERE PRESENT, BUT AFTER TIGHTENING THE SCREWS FURTHER THE IMPEDANCES WERE NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON (B)(6) 2013 THE PATIENT WENT TO SEE HIS DOCTOR FOR A BATTERY CHECK. IT WAS REPORTED THAT THE PROGRAMMER WAS FLASHING THE ELECTIVE REPLACEMENT INDICATOR (ERI), BUT THE PATIENT HAD JUST BEEN IMPLANTED IN (B)(6) 2013. THE HEALTH CARE PROVIDER (HCP) CHECKED THE BATTERY WITH THE CLINICIAN PROGRAMMER AND HE WAS SEEING THE SAME MESSAGE. THE HCP WAS TRYING TO PROGRAM THE PATIENT AND USED THE BIPOLAR SETTING OR 1+, 0- (WHICH HAD A VERY LOW IMPEDANCE OF 34 OHMS). IT WAS STATED THAT IN THE PROCESS OF PROGRAMMING THE HCP HAD CAUSED THE BATTERY TO "FLASH DRAIN" BELOW 2.6 V WHICH CAUSED THE ERI. THE ERI MESSAGE CANNOT BE REMOVED ONCE IT APPEARS. THE PATIENT'S ACTUAL VOLTAGE WAS 2.895 V, WHICH WAS "WELL ABOVE THE ERI WARNING". IT WAS STATED THAT THEY PATIENT'S THERAPY WAS NOT AFFECTED BY THE BIPOLAR LOW IMPEDANCE OF 1+, 0-; NOR BY THE ERI MESSAGE. THE PATIENT WAS ON A UNIPOLAR SETTING AND HIS TREMORS WERE "BEING CONTROLLED WELL". THE BATTERY WAS "WORKING PROPERLY" DESPITE THE FLASHING ERI MESSAGE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE INS WAS WORKING. IT WAS STATED THAT IT WAS UNCLEAR WHY PREVIOUSLY REPORTED READINGS HAD BEEN SEEN IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189633 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37602

    Patients

    Seq Age Sex Outcome Treatment
    1