BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3894399 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-12030
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# VA0J7PK, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT THERE WERE LOW OUT OF RANGE IMPEDANCE VALUE. IT WAS NOTED THAT THE CALL WAS MADE AT THE FIRST PROGRAMMING SESSION ON THE DATE OF THIS REPORT. THE CONTACT PAIR 0-1 WAS 36 OHMS, C-0 WAS 799, C-1 WAS 799. THE MANUFACTURING REPRESENTATIVE PROGRAMMED THERAPY FOR C-0. THE THERAPY IMPEDANCE WAS 843. IT WAS NOTED THAT THEY WOULD TRY SETTINGS TO SEE IF THE PATIENT GOT THERAPY AND MONITOR AT THE NEXT SESSION. NO OTHER ACTION WAS PLANNED. ADDITIONAL INFORMATION RECEIVED REPORTED THE LOW IMPEDANCES WERE NOT RESOLVED AND THE CAUSE WAS UNDETERMINED. IT WAS NOT DEVICE RELATED AND THERE WERE NO LEAD FRACTURES NOTED. THE PATIENT WAS DOING WELL JUST WAS UNABLE TO USE CONTACTS 0 AND 1 IN A BIPOLAR CONFIGURATION. IT WAS NOTED THAT ALL OTHER COMBINATIONS WERE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371333 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR