BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3142430 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08532
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3708695, SERIAL# (B)(4), IMPLANTED: 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# VA05SEK, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013 ELECTRODES 2 AND 3 HAD AN IMPEDANCE OF 174 OHMS. IT WAS NOTED THAT ON (B)(6) 2013 ELECTRODES 2 AND 3 HAD AN IMPEDANCE OF 2361 OHMS, AND ON (B)(6) 2013 ELECTRODES 2 AND 3 HAD AN IMPEDANCE OF 3188 OHMS. IT WAS REPORTED THAT ELECTRODE 1 NEGATIVE AND ELECTRODE 2 POSITIVE WERE USED FOR PROGRAMMING, AND THEY HAD AN IMPEDANCE OF 1021 OHMS. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED TO BE SEEN BY A HEALTHCARE PROVIDER THE DAY OF THE REPORT. IT WAS NOTED THAT THE PATIENT WAS GETTING GOOD BENEFIT, AND AT THE PATIENT¿S INITIAL PROGRAMING HE¿D HAD SIGNIFICANT DISABLING DYSKINESIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244064 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR