BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2711676 · Received August 23, 2012

    Report

    Report Number
    3004209178-2012-07255
    Event Type
    Malfunction
    Date Received
    August 23, 2012
    Report Date
    July 26, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3389S-40, LOT# V991333, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED HIGH IMPEDANCES. THE REPORTER STATED THAT X-RAYS WERE PERFORMED ON (B)(6) 2012 AND THERE WAS NO EVIDENCE OF ANY BREAKS. NO KNOWN SYMPTOMS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. IT WAS STATED THAT THE CURRENT ELECTRODE PAIRING WAS C+(ANODE) AND 1-(CATHODE) WITH GOOD THERAPY, NO SHOCKS. THE REPORTER STATED THAT THE IMPEDANCES WERE STILL HIGH, BUT NOW IN THE 26,000 OHMS RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PHYSICIAN WAS READING HIGH IMPEDANCES. THE PATIENT WAS IMPLANTED ABOUT 2-3 MONTHS AGO AND AT HER LAST FOLLOW-UP C1 AND C2 WERE HIGH. THE PHYSICIAN WAS REPORTING C1 AT 2708 OHMS AND REALIZED THE REPORT WOULD INDICATE OUT OF RANGE VALUES THAT ARE GREATER THAN 2000 OHMS AND THE PHYSICIAN DID NOT HAVE "KNOWN" VALUES AT SPECIFIC TEST AMPLITUDES. A PREVIOUS PAIR WAS 4300 OHMS, BUT WAS CURRENTLY AT 3333 OHMS ( DUE TO DIFFERENT VOLTAGES). THE IMPEDANCE PATTERN FOR THE DEVICE AND PATIENT HYDRATION WERE DISCUSSED. THE PATIENT HAD NO RETURN OF SYMPTOMS AND WAS NOT PROGRAMMED TO ANY OUT OF RANGE VALUES. THE PHYSICIAN WAS NO LONGER CONCERNED ABOUT THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1