BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5730241 · Received June 16, 2016

    Report

    Report Number
    3004209178-2016-12365
    Event Type
    Malfunction
    Date Received
    June 16, 2016
    Date of Event
    January 12, 2015
    Report Date
    June 16, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 37602, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389-40, LOT # J0217134V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 3389-40, LOT # J0217134V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATORS (INS) WERE NEARING END OF SERVICE (EOS) AND THE HCP WAS GOING TO SCHEDULE A REPLACEMENT SURGERY. ONE INS BATTERY WAS AT 2.68V AND THE OTHER WAS AT 2.77V. WHEN REVIEWING THE PATIENT¿S TELEMETRY STRIPS THEY NOTICED SOME IMPEDANCES WERE UNUSUAL AND HIGH. IMPEDANCES WERE MEASURED TO BE THE FOLLOWING: C-3 = 21152, 0-3 = 23000, 1-3 = 23880 AND 2-3 = 23700 OHMS. THE INS WAS PROGRAMMED TO 1-, 2+ WITH A THERAPY IMPEDANCE OF 781 OHMS. IN (B)(6) 2015, PAIRS WITH ELECTRODE 3 HAD IMPEDANCES IN THE 18000-20000 RANGE. ON 2015-06-01, PAIRS WITH ELECTRODE 3 HAD IMPEDANCES IN THE 15000 RANGE. ON (B)(6) 2015, PAIRS WITH ELECTRODE 3 HAD IMPEDANCES IN THE 8000 RANGE. THE HCP WAS GOING TO CONTINUE TO MONITOR THE PATIENT¿S THERAPEUTIC EFFECT, BUT IT WAS DIFFICULT TO KNOW IF THE PATIENT WAS GETTING GOOD THERAPY SINCE THEY ARE OLDER, IN A WHEEL CHAIR, AND NOT WALKING. THE HCP MET WITH THE PATIENT ON THE DAY OF THIS REPORT. THE CAUSE OF THE HIGH IMPEDANCES WAS NOT DETERMINED. THE ELECTRODES WITH HIGH IMPEDANCE WERE NOT GOING TO BE USED FOR THERAPY. THE IMPEDANCE ISSUE HAD NOT BEEN RESOLVED. THE PA IENT¿S INDICATION FOR USE IS PARKINSON¿S DUAL AND MOVEMENT DISORDERS. REFER TO MANUFACTURER REPORT #3004209178-2016-12363.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385198 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR