BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3875081 · Received June 16, 2014

    Report

    Report Number
    3004209178-2014-11641
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    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# VA0GNKF, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# VA0FBUN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCES WERE LOW. COMBINATION 0 AND 1 WAS 92 OHMS AND 2 AND 3 WAS 93 OHMS. THE PATIENT¿S LEFT SIDE LEAD WAS IMPLANTED ON THE DAY OF THE REPORT AND RETURNED THESE RESULTS POST-OPERATIVELY. THE SURGEON SAID THIS WAS OKAY AND THAT THEY WOULD PROGRAM AROUND IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352068 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR