BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSIGN? AMPLIFIER FOR LABSYSTEM? PRO EP RECORDING SYSTEM

    MDR report key: 4461100 · Received January 28, 2015

    Report

    Report Number
    2134265-2015-00348
    Event Type
    Malfunction
    Date Received
    January 28, 2015
    Date of Event
    December 16, 2014
    Report Date
    December 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - LOWELL, MA
    Product Code
    DQK
    PMA / PMN Number
    K031000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE RESULTS OF THE TESTING INDICATED THAT THE RETURNED CLEARSIGN AMPLIFIER AS WELL AS THE ASSOCIATED COMPLAINT CARTO CABLE PASSED INCOMING INSPECTION TESTS, INCLUDING NOISE AND LEAKAGE TESTING. THE POSSIBILITY OF INTERACTION EFFECTS BETWEEN THE TWO COMPONENTS AS A CAUSE WAS ELIMINATED BY TESTING THE RETURNED COMPLAINT AMPLIFIER AND CABLE TOGETHER AND FOUND NO ISSUES. BOTH DEVICES PERFORMED AS EXPECTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE CAUSE OF THE REPORTED DIFFICULTIES MAY BE DUE INTERACTION WITH ANOTHER DEVICE. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR 2134265-2015-00590. IT WAS REPORTED THAT UNINTENDED RF ENERGY WAS DELIVERED TO THE PATIENT. DURING AN ABLATION PROCEDURE, 10HZ NOISE WAS SEEN ON THE ABLATION CHANNEL WHEN NO RF ENERGY WAS APPLIED. SOMEHOW THERE WAS PACING CAPTURED IN THE ATRIUM FOR THE ABLATION CATHETER (10HZ), INDICATING THE ABLATION CATHETER WAS SENDING ENERGY INTO THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS IN GOOD CONDITION. NO ADDITIONAL TREATMENT WAS REQUIRED.

    Description of Event or Problem · 1

    SAME CASE AS MDR 2134265-2015-00590. IT WAS REPORTED THAT UNINTENDED RF ENERGY WAS DELIVERED TO THE PATIENT. DURING AN ABLATION PROCEDURE, 10HZ NOISE WAS SEEN ON THE ABLATION CHANNEL WHEN NO RF ENERGY WAS APPLIED. SOMEHOW THERE WAS PACING CAPTURED IN THE ATRIUM FOR THE ABLATION CATHETER (10HZ), INDICATING THE ABLATION CATHETER WAS SENDING ENERGY INTO THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS IN GOOD CONDITION. NO ADDITIONAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65826 CLEARSIGN? AMPLIFIER FOR LABSYSTEM? PRO EP RECORDING SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC - LOWELL, MA H30120012670

    Patients

    Seq Age Sex Outcome Treatment
    1 STOCKERT GENERATOR, BIOSENSE WEBSTER| CLEARSIGN CARTO 3 CABLE| SMARTTOUCH CATHETER