BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 3202204 · Received June 28, 2013

    Report

    Report Number
    3009448963-2013-00077
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS SEEN AT THE CLINIC APPROXIMATELY ONE WEEK LATER. UPON INTERROGATING THE DEVICE USING THE OLD SMR5 SOFTWARE, A RED SCREEN APPEARED WHICH WAS A RESULT OF A DA ERROR. A CAMERON HEALTH ENGINEER WAS CONTACTED AND GUIDED THE FIELD REPRESENTATIVE THROUGH PROGRAMMER STEPS AND THEN INTERROGATING THE DEVICE AGAIN. PROGRAMMING CHANGES WERE MADE TO THE DEVICE WITH NO FURTHER ERRORS. THE DEVICE WAS REINTERROGATED AGAIN WITH THE SMR5 SOFTWARE TO ALLOW ALL LOGFILES TO BE UPLOADED TO THE PROGRAMMER, THEN EXITED THE SESSION SUCCESSFULLY. NEXT A MAGNET RESET WAS PERFORMED WHICH PRODUCED THE EXPECTED 5 TONES FOLLOWED BY A WARBLE TONE. THE MAGNET WAS THEN REAPPLIED AND PRODUCED R-WAVE SYNCHRONOUS TONES AS EXPECTED. NEXT, SMR6 SOFTWARE WAS USED TO INTERROGATE THE DEVICE THE DEVICE WHICH WAS SUCCESSFUL. ALL PROGRAMMED SETTINGS WERE THE SAME AS OBSERVED IN THE PREVIOUS SMR5 INTERROGATION AND NO ERRORS WERE OBSERVED. THE DEVICE WAS THEN REINTERROGATED USING THE SMR6 AND NO FURTHER ISSUES WERE OBSERVED. THE FIELD REPRESENTATIVE UPLOADED SD CARD DATA FROM BOTH PROGRAMMERS (USING SMR5 AND SMR6 SESSIONS) FURTHER ANALYSIS AND LOGFILE REVIEWS ARE PENDING TO INVESTIGATE THE BIT FLIP THAT MAY HAVE OCCURRED IN THE FLASH MEMORY OF THE DEVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW-UP APPOINTMENT, THE DEVICE WAS INTERROGATED USING THE SMR6 SOFTWARE, HOWEVER, THE PROGRAMMER DISPLAYED AN ERROR STATING THE DEVICE NEEDED TO BE UPDATED WITH THE NEW FIRMWARE. THE PROGRAMMER ATTEMPTED TO INSTALL THE UPDATED FIRMWARE, BUT WAS UNSUCCESSFUL. A MAGNET WAS THEN APPLIED AND THERE WAS A RESPONSE. BOSTON SCIENTIFIC TECHNICAL SERVICE (TS) WAS CONTACTED AND RECOMMENDED DOING A MEMORY DOWNLOAD OR TO TRY AND INTERROGATE THE DEVICE USING THE SMR5 SOFTWARE. A MEMORY DOWNLOAD WAS PERFORMED AND THE LOGFILES WERE REVIEWED. IT WAS NOTED THAT THE PROGRAMMER WAS UNABLE TO ERASE THE FLASH MEMORY WHICH WAS REQUIRED TO DOWNLOAD THE SOFTWARE. IT WAS ALSO NOTED THAT THE PATIENT RECENTLY HAD RADIATION THERAPY TREATMENT SO TS STATED IT WAS POSSIBLE THE DEVICE HAD SOME MEMORY CORRUPTION AS A RESULT. TS DISCUSSED INTERROGATING THE DEVICE TO COLLECT ALL AVAILABLE DATA FOR ANALYSIS AND DEPENDING ON INTERROGATION RESULTS, THE NEXT STEP MAY BE TO ATTEMPT A MAGNET RESET ON THE DEVICE AND THEN DETERMINE IF THE DEVICE SHOULD BE REPLACED IF NECESSARY BECAUSE A MAGNET RESET COULD AFFECT FUTURE DEVICE OPERATION (I.E., TELEMETRY ISSUES AND POSSIBLY PREVENTING THERAPY). TS NOTED IF THE MAGNET RESET IS SUCCESSFUL, THEN TRY AND DOWNLOAD THE CURRENT SOFTWARE TO THE PROGRAMMER. THE CLINIC SCHEDULED ANOTHER APPOINTMENT WITH THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295312 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLTOR - PROD CODE LWS LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 3400| 1010