BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOCONSOLE

    MDR report key: 3902041 · Received June 30, 2014

    Report

    Report Number
    3002648230-2014-00104
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    LPB
    PMA / PMN Number
    P020045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS. RESULTS OF INVESTIGATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    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 HAS BEEN CONFIRMED BY FIELD SERVICE ENGINEERING. THE ISSUE WAS RESOLVED BY REPLACING THE CONSOLE PATIENT BOARD. THIS REPORT WILL BE RECORDED AND TRENDED.

    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 HAS BEEN CONFIRMED BY FIELD SERVICE ENGINEERING. THE ISSUE WAS RESOLVED BY REPLACING THE CONSOLE PATIENT BOARD. THE DEFECTIVE PATIENT BOARD WAS RETURNED FOR ANALYSIS. THE PATIENT BOARD WAS INSPECTED AND ASSEMBLED TO A CRYOCONSOLE. THE CONSOLE WAS REBOOTED AND FAILED THE POWER UP TEST. THE REPORTED ISSUE ¿NO INPUT DETECTED¿ HAS BEEN CONFIRMED THROUGH TESTING.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE USER WAS UNABLE TO BEGIN A CRYOABLATION PROCEDURE DUE TO AN ISSUE WITH THE CRYOCONSOLE. IT WAS REPORTED THAT THE SCREEN OF THE CRYOCONSOLE SHOWED THE MESSAGE "NO INPUT DETECTED" AND THAT THE CRYOCONSOLE WOULD NOT POWER ON. THE CASE WAS ABORTED; THE PATIENT WAS INTUBATED AND 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
    380095 CRYOCONSOLE CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC CRYOCATH LP 106A3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other