BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO II SERIES 200 PULSE GENERATOR

    MDR report key: 107362 · Received July 21, 1997

    Report

    Report Number
    2522457-1997-00010
    Event Type
    Injury
    Date Received
    July 21, 1997
    Date of Event
    May 29, 1997
    Report Date
    June 19, 1997
    Manufacturer
    CARDIAC CONTROL SYSTEMS, INC
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PACEMAKER WAS EXPLANTED DUE TO PT PRESENTED WITH INFECTION. NON-DEVICE RELATED. A. SUMMARY OF COMPLAINT - THE PACEMAKER WAS EXPLANTED FOR AN INFECTION 4.5 MONTHS POST-IMPLANT FOR INFECTION. B. DEVICE HISTORY AND COMPLAINT DATA BASE SEARCH. 1. DEVICE HISTORY - THERE IS NO INFO IN THE DEVICE HISTORY RECORD THAT IS APPLICABLE TO THIS COMPLAINT (SEE STERILE HISTORY FOR STERILE LOT INFO). 2. COMPLAINT DATA BASE SEARCH - THERE ARE NO OTHER COMPLAINTS OF INFECTION FROM THIS STERILE LOT. INFECTION OCCURRING AT 4.5 MONTHS POST IMPLANT HAS OCCURRED ONLY FOUR TIMES SINCE 1985 AND IN THESE CASES THE INFECTION WAS FOUND TO BE OF A CLINICAL ORIGIN OR THE ORIGIN WAS NOT DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED. C. VISUAL EXAMINATION: 1. UNAIDED EYE- THE PACEMAKER PRESENTED A NORMAL APPEARANCE WHEN VIEWED WITH NO MAGNIFICATION. 2. MICROSCOPIC EVALUATION - THE PACEMAKER PRESENTED A NORMAL APPEARANCE WHEN VIEWED AT 10X. D. ELECTRICAL EVALUATION: 1. ALL DATA PRINTOUT - AN ALL DATA PRINTOUT WAS OBTAINED IN THE "AS RECEIVED" CONDITION ON 20 OCT 1997. THE PACEMAKER WAS IN THE VVI MODE WITH A PACING RATE OF 60 PPM. THE VENTRICULAR PULSE WIDTH WAS .6 MSEC, THE VENTRICULAR PULSE AMPLITUDE WAS 3.5 V, THE VENTRICULAR REFRACTORY PERIOD WAS 280 MSEC, AND THE VENTRICULAR SENSITIVITY WAS L 2.5 MV. THE BATTERY CELL VOLTAGE WAS 2.78 V. 2. ELECTRICAL TEST - NO ELECTRICAL TEST WAS PERFORMED ON THIS PACEMAKER AT THIS TIME. D. X-RAY ANALYSIS- NA. E. BIOLOGICAL CULTURE/STERILE HISTORY. 1. BIOLOGICAL CULTURE - THE PACEMAKER WAS ASEPTICALLY PLACED INTO 200 ML. OF TRYPTIC SOY BROTH ON 25 JUNE 1997. ON 27 JUNE 1997 THE PACEMAKER CULTURE EXHIBITED GROWTH OF COCCI OCCURRING IN PAIRS AND IRREGULAR CLUSTERS. ON 14 JULY THE CULTURE WAS TAKEN TO A HOSP FOR IDENTIFICATION AND ANTIBOTIC SUSCEPTIBILITY TESTING. THE GROWTH WAS IDENTIFIED AS CANDIDA ALBICANS, A YEAST MICROORGANISM. THE ANTIBIOTIC SUSCEPTIBILITY TESTING WAS NOT PERFORMED BECAUSE THE SPECIES ISOLATED WAS A YEAST. 2. STERILE HISTORY- THIS PACEMAKER WAS STERILIZED AS A PART OF STERILE LOT 960201. THE BIOBURDEN FOR THE PACEMAKER SAMPLE IN THIS LOT WAS 2 CFU'S (COLONY FORMING UNITS) AND ALL TESTING FOR THE LOT WAS SUCCESSFULLY COMPLETED WITH NO FAILURES FOUND. F. ADD'L COMMENTS - THIS PACEMAKER WAS REPORTED AS HAVING BEEN DECONTAMINATED PRIOR TO RETURN TO CCS. G. CONCLUSIONS - THERE IS NO INDICATION THAT THE INFECTION WAS THE RESULT OF A NON-STERILE DEVICE FOR A NUMBER OF REASONS; ALL TESTING WAS COMPLETE WITH NO FAILURES FOUND, AND THE STERILIZATION CYCLE IN USE HAS DEMONSTRATED THE ABILITY TO SUCCESSFULLY STERILIZE CHALLENGES OF 1 X 10 TO THE 6 POWER SPORES OF BACILLUS SUBTILLIS VAR. NIGER (THE RECONGNIZED SEVEREST CHALLENGE FOR AN ETHYLENE OXIDE STERILIZATION METHOD) AND THERE HAVE BEEN NO OTHER REPORTS OF INFECTION INVOLVING DEVICES FROM THIS STERILE LOT. ALSO THE ORGANISM IDENTIFIED IS A YEAST AND NO YEAST ORGANISMS HAVE BEEN ISOLATED FROM EITHER PROUCT OR THE ENVIRONMENT AT CCS. CANDIDA ALBICANS IS A FREQUENTLY ISOLATED SPECI

    Description of Event or Problem · 1

    ON 1/8/97, A 92 YEAR OLD MALE PT WAS IMPLANTED WITH A UNIPOLAR SINGLE-CHAMBER PACEMAKER AND ANOTHER MFR'S LEAD. ON 6/19/97, THE MFR RECEIVED A REPORT THAT THE ABOVE REFERENCED PT HAD DEVELOPED AN INFECTION. ON 5/29/97, THE PHYSICIAN ELECTED TO EXPLANT THE PACEMAKER AND LEAD AND REPLACED IT WITH ANOTHER 231 PACEMAKER AND ANOTHER MFR'S LEAD. COMPLICATION WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO II SERIES 200 PULSE GENERATOR Implant PACEMAKER DXY CARDIAC CONTROL SYSTEMS, INC 231 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization