BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3143089 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08557
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387S-40 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3387S-40 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37642 LOT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37651 LOT# SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3708660 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708660 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S RIGHT LEAD LOOKED ¿A LITTLE BENT¿ AT THE THIRD CONTACT. IT WAS NOTED, THE LEAD END CAPS CAME OFF ¿CLEAN¿ AND THERE WAS NO RESISTANCE FOR EITHER LEAD. WHEN IMPEDANCES WERE MEASURED COMBINATIONS WITH CONTACT THREE FOR THE LEFT LEAD WERE HIGH, BETWEEN 21 ,000 AND 24,000 OHMS, BUT IT WAS NOTED THEY WERE NOT OUT OF RANGE. IT WAS NOTED, THE SURGEON NOTICED THERE WAS ¿A LITTLE BIT OF FLUID IN THERE.¿ THE IMPEDANCES WERE CHECKED FOR A THIRD TIME IN THE OPERATING ROOM AND COMBINATIONS WITH CONTACT 3 WERE THEN BETWEEN 15,000 AND 17,000 OHMS. POST-OPERATIVE MEASUREMENTS SHOWED THE RIGHT LEAD WAS STILL NORMAL AND COMBINATIONS WITH CONTACT 3 FOR THE LEFT LEAD WERE BETWEEN 20,000 AND 23,000 OHMS. IT WAS ALSO REPORTED, THE PATIENT¿S RECHARGE INTERVAL WAS CALCULATED BASED OFF OF HIS PROGRAMMING AND IT WAS EXPECTED HE HAD 3.3 WEEKS UNTIL HE WAS ¿EMPTY.¿ ADDITIONAL INFORMATION RECEIVED NINE DAYS LATER REPORTED, THE PATIENT¿S IMPEDANCES WERE CHECKED AGAIN AND COMBINATIONS ON THE LEFT LEAD WITH CONTACT 3 WERE STILL HIGH BUT THEY HAD DECREASED SIGNIFICANTLY, RANGING FROM 4640 TO 6067 OHMS, VERSUS THE FIRST REPORT. IT WAS REPORTED, THE THERAPY IMPEDANCE FOR THE LEFT LEAD WHEN MAPPING AT 5 VOLTS WAS HIGH WITH CASE POSITIVE AND CONTACT 3 NEGATIVE. IT WAS NOTED THERE WERE NO PROBLEMS WITH THE RIGHT LEAD. ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS HARD TO SAY IF THE PATIENT WAS RECEIVING THERAPY. IT WAS NOTED NO SIDE EFFECTS WERE SEEN WITH CONTACT 3 AT 5V.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244529 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1