BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3797414 · Received May 7, 2014

    Report

    Report Number
    3004209178-2014-08676
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    December 13, 2012
    Report Date
    April 17, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 64002, LOT# N352924, IMPLANTED: 2012 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 3387S-40 LOT# V014246, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3387S-40, LOT# V014246, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE HIGH IMPEDANCES FOR ALL CONTACT PAIRS INVOLVING ELECTRODE 4. NO DIAGNOSTIC TESTS HAD BEEN PERFORMED. NO ACTION HAD BEEN TAKEN AND THE EVENT WAS CONSIDERED ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273531 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR