BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3843524 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09968
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37602, SERIAL# (B)(4), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# VA07VDZ, PRODUCT TYPE LEAD; PRODUCT ID 748351, SERIAL# (B)(4), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEUROSTIMULATOR, SERIAL # (B)(4), FOUND NO ANOMALY. THE STIMULATOR WAS CONNECTED TO A KNOWN GOOD EXTENSION AND LEAD AND GOOD IMPEDANCES WERE SEE ON EVERY ELECTRODE PAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE IMPEDANCES GREATER THAN 4,000 OHMS ON SOME OF THE BIPOLAR AND UNIPOLAR PAIRS. THE REPORTER CALLED INTER-OPERATIVELY AND STATED THAT CONTACT 0 HAD HIGH IMPEDANCES, 12,000 TO 14,000 OHMS, ON BOTH UNIPOLAR AND BIPOLAR PAIRS. THE REPORTER STATED THAT DURING LEAD TESTING CONTACT 0 WAS USED TO PROVIDE THERAPY AND IT WORKED FINE. THE DOCTOR REPLACED THE EXTENSION AND THERE WERE STILL HIGH IMPEDANCES, SO THE DOCTOR WANTED TO TRY ANOTHER IMPLANTABLE NEUROSTIMULATOR (INS). THE INS WAS REPLACED, BUT STILL PRODUCED HIGH IMPEDANCES THIS TIME BETWEEN 11,000 AND 13,500 OHMS. FIVE DAYS LATER IT WAS REPORTED THAT THERE WAS MOST LIKELY A PROBLEM WITH THE 0 CONTACT. THE PATIENT WOULD BE TURNED ON IN THREE WEEKS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS TURNED ON WITH GOOD THERAPEUTIC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322505 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR