BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 1566668 · Received December 15, 2009

    Report

    Report Number
    3004209178-2009-09343
    Event Type
    Malfunction
    Date Received
    December 15, 2009
    Date of Event
    January 1, 2009
    Report Date
    November 19, 2009
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009/S05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    UPON TESTING THE PROGRAMMER AND SHOWING THE PT HOW TO USE IT, THE ELECTIVE REPLACEMENT INDICATOR MESSAGE WAS DISPLAYED. THE NURSE THEN INTERROGATED WITH THE CLINICIAN PROGRAMMER AND THE SAME MESSAGE APPEARED. THE BATTERY VOLTAGE MEASURED AT 2.62V. THE BEGINNING VOLTAGE WAS UNK. THE PT HAD NOT EXPERIENCED ANY FALLS OR TRAUMA. ELECTRODE PAIR 1,3 ON LEFT LEAD HAD AN IMPEDANCE OF 34 OHMS. THE LEFT SIDE GROUP IMPEDANCE WAS 75 OHMS; THE RIGHT SIDE WAS 835 OHMS. THE NURSE WAS GOING TO TRY TO REPROGRAM THE DEVICE THOUGH THE PT WAS GETTING GREAT RESULTS WITH THE PROGRAM THAT WAS SET. THE DEVICE WAS PROGRAMMED AS FOLLOWS: LEFT SIDE, 1-, 2-, 3+, 4.8V, 70PW, 130HZ, ELECTRODE IMPEDANCES C/0: 1458, C/1: 850, C/2: 1236, C/3: 846, 0/1: 1788, 0.2: 2221, 0.3: 1788, 1/2: 1493, 1/3: 34, 2/3: 1493, ALL IN OHMS. RIGHT SIDE, C+, 10-, 2.3V, 60PW, 130HZ, ELECTRODE IMPEDANCES C/8: 1189, C/9: 1127, C/10: 901, C/11: 1372, 8/9: 1603, 8/10: 1648, 8/11: 2117, 9/10: 1386, 9/11: 1995, 10/11: 1589, ALL IN OHMS. SURGERY WAS SCHEDULED FOR (B) (6) 2009 TO TROUBLESHOOT THE SYSTEM AND POSSIBLY REPLACE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN001360V| IMPLANTED:| LEAD: MODEL 3387S, LOT# V284893| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ100990N| LEAD: MODEL 3387S, LOT# V284893