BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO II SAVVI SERIES 300

    MDR report key: 94677 · Received May 29, 1997

    Report

    Report Number
    2522457-1997-00007
    Event Type
    Injury
    Date Received
    May 29, 1997
    Date of Event
    October 30, 1996
    Report Date
    April 28, 1997
    Manufacturer
    CARDIAC CONTROL SYSTEMS, INC
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL RETURNED PACEMAKER EVAL: DATE: 1/15/1998. 1. DEVICE HISTORY - THERE IS NOTHING IN DEVICE HISTORY RECORD FOR THIS PACEMAKER THAT IS PERTINENT TO THIS COMPLAINT. IMPLANT HISTORY SHOWS BEING IMPLANTED ON 2/1/1994 BY PHYSICIAN WITH SETTINGS OF 3.5 VOLT PULSE AMPLITUDE, 0.6 MILLISECONDS PULSE WIDTH, AND 280 MILLISECOND REFRACTORY PERIOD. THIS SAME DR IN REPORT WITH STUDY DATE OF 10/30/1996 REPORTED "EXCHANGE OF CARDIAC CONTROL 333 PULSE GENERATOR PROGRAMMED AS VDD WITH INTERMEDICS 292-06 PULSE GENERATOR PROGRAMMED AS VDDR." EXPLANTED PULSE GENERATOR WAS RECEIVED (6) MONTHS LATER ON 4/28/1997 FROM INTERMEDICS IN EOS STATUS WITH DIFFERENT PROGRAM PARAMETERS OF 5.0 VOLTS PULSE AMPLITUDE, 0.5 MILLISECONDS PULSE WIDTH, AND 240 MILLISECOND REFRACTORY PERIOD. 2. COMPLAINT DATA BASE SEARCH - PULSE GENERATOR #333-01153 WAS IMPLANTED ON 6/5/1993 AND EXPLANTED 38 MONTHS LATER ON 8/11/1996 REPORTEDLY DUE TO BEING FOUND IN EOS STATUS. ITS BATTERY WAS ESTIMATED 50% DEPLETED BY X-RAY VISUAL ANALYSIS. BOTH THE GENERATOR'S OPERATION AND ITS INTERNAL ELECTRONICS PASSED QA ELECTRICAL ACCEPTANCE TESTS. BATTERY WAS SENT TO WILSON GREATBATCH FOR ANALYSIS. THEY REPORTED NO ANOMALIES AND CONFIRMED BATTERY'S DEPLETION TO BE 47%. RETURNED PACEMAKER EVAL RECORDS REVEAL TWO SIMILAR ISOLATED OCCURANCES INVOLVING ANOTHER CCS PACEMAKER MODEL, MODEL 118. MODEL 118 ELECTRONIC COMPONENTS ARE SIGNIFICANTLY DIFFERENT THAN MODEL 333 BUT SAME BATTERY TECHNOLOGY AND BATTERY SUPPLIER ARE USED IN ALL CASES. BATTERY SUPPLIER, IN BOTH OF THOSE CASES REPORTED NO ABNORMAL OR DEFECTIVE CONDITION BUT CONFIRMED SIGNIFICANT DEPLETION, YET NOT ENOUGH TO SUPPORT PULSE GENERATOR REACHING EOS STATUS. B. VISUAL EXAMINATION: 1. UNAIDED EYE - PACEMAKER PRESENTED NORMAL APPEARANCE WHEN VIEWED WITH NO MAGNIFICATION. 2. MICROSCOPIC EXAMINATION - PACEMAKER PRESENTED NORMAL APPEARANCE WHEN VIEWED AT 10X. 3. ELECTRICAL EVAL: 1. ALL DATA PRINTOUT - ALL DATA PRINTOUT WAS OBTAINED IN "AS RECEIVED" CONDITION AT ROOM TEMPERATURE ON 4/28/1997. PACKMAKER WAS IN VVI MODE AND HAD PACING RATE OF 50 PPM. VENTRICULAR PULSE AMPLITUDE WAS 5.0V, VENTRICULAR PULSE WIDTH WAS 0.5 MSEC, VENTRICULAR REFRACTORY PERIOD WAS 240 MSEC, AND VENTRICULAR SENSITIVITY WAS L2.5 MV. PACEMAKER WAS IN EOS STATUS. 2. ELECTRICAL TEST (QA) - NO ELECTRICAL WAS PERFORMED ON 4/28/1997 BECAUSE THIS TEST WOULD RELEASE ITS EOS STATUS AS HAPPENED WITH INVESTIGATION OF. INSTEAD IT WAS ELECTED TO DOWNLOAD PULSE GENERATOR'S SHIFT REGISTER TO SEE IF SOME PRECONDITION HAD PREMATURELY TRIGGERED ITS EOS STATUS. 3. ELECTRICAL INTERROGATION (R&D) - ALTHOUGH INTERIM REPORT ON THIS RETURNED PACEMAKER CONCLUDED THAT EOS STATUS WAS NOT COLD INDUCED (SUPPLIER VOLTAGES AT LOWER TEMPERATURES) THIS COULD NOT BE SUBSTANTIATED BY FURTHER ANALYSIS. IN FACT, EOS SHIFT REGISTER BIT IS SET DIRECTLY FROM BATTERY'S OUTPUT VOLTAGE REGARDLESS OF HOW THAT REDUCED CONDITION IS BROUGHT ABOUT.

    Description of Event or Problem · 1

    ADDITIONAL TESTING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO II SAVVI SERIES 300 Implant PULSE GENERATOR DXY CARDIAC CONTROL SYSTEMS, INC 333 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization