BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6220762 · Received January 3, 2017

    Report

    Report Number
    3004209178-2017-00120
    Event Type
    Malfunction
    Date Received
    January 3, 2017
    Date of Event
    December 5, 2016
    Report Date
    March 24, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID NEU_UNKNOWN_EXT, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED A CONSUMER¿S IMPLANTABLE NEUROSTIMULATOR (INS) DISPLAYED ERI (ELECTIVE REPLACEMENT INDICATOR) WITH A BATTERY VOLTAGE OF 2.79V WHEN AN ERI SHOULD NOT BE INDICATED UNTIL VOLTAGE IS 2.6V. AT OUTPATIENT FOLLOW-UP, THE CONSUMER COMPLAINED OF PAIN AT THE SAME TIME WHEN STIMULATION WAS OFF AN D ON. DEVICE SETTINGS WERE AS FOLLOWS: 3.6 V, 201 PW, 185 HZ, C+0-, AND IMPEDANCES BETWEEN 975 OHMS AND 2389 OHMS. ON (B)(6) 2016, AN INS REPLACEMENT WAS PERFORMED; THE CONSUMER HAD NO FEELING OF PAIN WITH DECREASE IN OUTPUT. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE REPORTED THAT AT THE REPLACEMENT PROCEDURE, IT WAS CONFIRMED THAT NEITHER THE LEAD NOR THE ADAPTER/EXTENSION WAS SHORT-CIRCUITED. ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE REPORTED THAT A POWER ON RESET (POR) HAD OCCURRED AND THE CLOCK SETTING WAS CHANGED, AND WAS PERHAPS RELATED TO THE ERI ISSUE. THERE WERE NO OUT OF RANGE ELECTRODE IMPEDANCE. THE HCP NOTED THE CONSUMER FELT PAIN WHEN THE STIMULATION WAS TURNED ON AFTER THE POR. AFTER REPLACING THE INS, THE HCP REDUCED THE AMPLITUDE TO REDUCE THE PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THE CAUSE OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) AT 2.79V WAS NOT DETERMINED. NO TROUBLESHOOTING WAS DONE PRIOR TO THE INS REPLACEMENT AND NO FURTHER ISSUES HAVE BEEN REPORTED SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1