BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCONSOLE

    MDR report key: 3746050 · Received April 11, 2014

    Report

    Report Number
    3002648230-2014-00065
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    LPB
    PMA / PMN Number
    P020045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT NOT MARKETED IN THE US, BUT IS SIMILAR TO UNIVERSAL CRYOCONSOLE MARKETED IN THE US (PMA # P020045). BIN FILES AND FAILURE FILES WERE REVIEWED AND DID NOT SHOW ANY SYSTEM NOTICES FOR THE DATE OF EVENT. VERIFICATION OF THE CATHETER USED DURING THE CASE INDICATED THAT THE CATHETER HAD BEEN USED FOR 5 INJECTIONS. THE CONSOLE PERFORMANCE WAS EVALUATED ON SITE BY FIELD SERVICE ENGINEERING. THE CONSOLE FAILED THE INSPECTION DUE TO A DEFECTIVE WATCHDOG BOARD. REPLACEMENT OF THE CONSOLE WATCHDOG BOARD RESOLVED THE ISSUE. THIS REPORT WILL BE RECORDED AND TRENDED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT NOT MARKETED IN THE US, BUT IS SIMILAR TO UNIVERSAL CRYOCONSOLE MARKETED IN THE US (PMA # P020045). INVESTIGATION OF CRYOCONSOLE PERFORMANCE IS IN PROGRESS; RESULTS OF EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE USER WAS UNABLE TO COMPLETE A CRYOABLATION PROCEDURE DUE TO ISSUES WITH THE CRYOCONSOLE. THE CASE WAS ABORTED; THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR THE PROCEDURE. NO PATIENT COMPLICATION REPORTED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE USER WAS UNABLE TO BEGIN A CRYOABLATION PROCEDURE DUE TO ISSUES WITH THE CRYOCONSOLE. THE CASE WAS ABORTED; THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR THE PROCEDURE AND DID NOT RECEIVE ANY THERAPEUTIC TREATMENT. NO PATIENT COMPLICATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220550 CRYOCONSOLE CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC CRYOCATH LP 106E2

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Other