BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCONSOLE

    MDR report key: 3955681 · Received July 24, 2014

    Report

    Report Number
    3002648230-2014-00122
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    May 15, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    LPB
    PMA / PMN Number
    P020045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SUPPORT WAS NOTIFIED OF THIS OCCURRENCE. UPON REVIEW OF COMPLAINT INFORMATION, A SERVICE ORDER WAS INITIATED TO REVIEW THE CONSOLE PERFORMANCE ON SITE. THE REPORTED ISSUE WAS REPRODUCIBLE DURING SITE VISIT. THE CONSOLE FAILED THE INSPECTION DUE TO A DEFECTIVE LOW PRESSURE REGULATOR AND VALVE BOARD. AN INTERNAL CAPA HAS BEEN INITIATED TO INVESTIGATE THE CONDITION FOUND FOR THE LOW PRESSURE REGULATOR. THIS REPORT WILL BE RECORDED AND TRENDED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CRYOCONSOLE WAS TAKING LONGER THAN USUAL TO INFLATE THE BALLOON OF THE CRYOABLATION CATHETER. THERE WERE NO ISSUES DURING ABLATION AND THE CRYOABLATION PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. REPORTABLE BASED ON INVESTIGATION COMPLETED (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434081 CRYOCONSOLE CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC CRYOCATH LP 106A3

    Patients

    Seq Age Sex Outcome Treatment
    1