BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4882700 · Received July 1, 2015

    Report

    Report Number
    3004209178-2015-12555
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MFR
    PMA / PMN Number
    H050003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387S-40, LOT# V458446, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V458446, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SETTINGS WERE CHANGED TO VOLTAGE MORE PER THE HEALTHCARE PROFESSIONAL¿S REQUEST. THE CAUSE OF THE HIGH IMPEDANCE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT铠HEALTHCARE PROFESSIONAL (HCP) WAS TRYING TO CHANGE THE IMPLANTABLE NEUROSTIMULATOR (INS) FROM CONSTANT VOLTAGE MODE TO CONSTANT CURRENT MODE AND THEY WERE GETTING A MESSAGE ON THE CLINICIAN PROGRAMMER STATING "VALUE ENTERED IS NOT POSSIBLE IN CURRENT SETTINGS." THE HCP SAW THE MESSAGE WHEN INCREASING THE INS UP TO 6.2 MA WHEN THEY WERE TRYING TO REACH 6.5 MA. THE HCP HAD DIFFICULTY PROGRAMMING THE INS TO THE DESIRED CURRENT AND THEY HAD NOT CHECKED IMPEDANCES. THE INS WAS PROGRAMMED WITH ONE ANODE AND ONE CATHODE WITH A 90 USEC PULSE WIDTH AND A RATE OF 130 HZ. A WEEK LATER, THE MANUFACTURING REPRESENTATIVE REPORTED THEY WERE NOT ABLE TO ADJUST STIMULATION AND A "CALL YOUR DOCTOR" ICON AND OUT OF REGULATION (OOR) MESSAGE WAS DISPLAYED ON THE PATIENT PROGRAMMER. THE PATIENT WAS HAVING A RECURRENT OOR ON ONE OF THEIR INS. THE PATIENT'S OTHER INS DID NOT SHOW OOR ON THE PROGRAMMER. SINCE THE PATIENT WAS REPROGRAMMED, THEY HAD BEEN HAVING TROUBLE WITH THE PROGRAMMER. THE REPORTER THOUGHT THE PATIENT WAS NOT TRYING TO CHANGE SETTINGS, BUT THEY SAW THE OOR ON THE PROGRAMMER WHEN THEY SYNCED WITH THE INS. THE INS WAS 75 PERCENT CHARGED WHEN THE OOR OCCURRED AND THE PATIENT WAS PROGRAMMED TO HIGHER SETTINGS. SEVERAL DAYS LATER THE MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT TO MEASURE IMPEDANCES. THE INS WAS CURRENTLY PROGRAMMED TO C+, 1- AT 6.5V, 90 USEC, AND 130 HZ. THERAPY IMPEDANCES WERE MEASURED AND "XXX" WAS DISPLAYED. THE MANUFACTURING REPRESENTATIVE CHANGED THERAPY TO 3 MA AND THERAPY IMPEDANCES WERE MEASURED TO BE 2103 OHMS. THERAPY WAS INCREASED TO 4 MA AND THERAPY IMPEDANCES WERE MEASURED TO BE 2153 OHMS. THE PATIENT HAD NO FALLS AND THE INS WAS 75 PERCENT CHARGED AT THE TIME OF THIS REPORT. ELECTRODE IMPEDANCES WERE MEASURED TO BE THE FOLLOWING: C-0 = 5082, C-1 = 2481, C-3 = 2600, 0-2 = 4680, AND 0-3 = 5876 OHMS. ELECTRODE IMPEDANCES WERE MEASURED AGAIN AT 3V AND AT 3V WITH THE PATIENT'S HEAD LEANED BACK AND THE SAME ELECTRODES REMAINED HIGH. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425789 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MFR MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR