BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3120394 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07899
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 30, 2013
    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 PRODUCTS: PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# VA06GXL, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# VA06GXL, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT# VA06GXL, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW IMPEDANCES WERE SEEN INTRA-OPERATIVELY ON THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS). SPECIFICALLY, IMPEDANCE VALUES OF 38 OHMS WERE SEEN ON ELECTRODES #0 AND 1 AND VALUES OF 36 OHMS WERE NOTED ON ELECTRODE #8 AND 10. THE TAILS OF THE EXTENSIONS WERE THEN SWITCHED AND THE LOW IMPEDANCES FOLLOWED (NOW SEEN ON ELECTRODES 0 <(>&<)> 2, 8 <(>&<)> 9). FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2013 REPORTED THAT IT WAS DETERMINED THAT THE CAUSE OF THE IMPEDANCE ISSUE WAS THE RIGHT LEAD. AFTER SWITCHING AND CLEANING OFF THE CONNECTIONS AT BOTH THE LEAD AND BATTERY SITES, THE LEFT SIDE COMPONENTS CHECKED OUT FINE. THE RIGHT SIDE STILL SHOWED LOW IMPEDANCE VALUES ON ELECTRODES 8 AND 10. ADDITIONAL FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2013 CONFIRMED THAT THERE WAS A SHORT CIRCUIT BETWEEN CONTACTS 8 AND 10. THE PATIENT WAS THEN PROGRAMMED AROUND THE AFFECTED CONTACTS. THE PATIENT WAS REPORTED AS DOING ¿OKAY¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222522 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1