BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION

    MDR report key: 8159539 · Received December 13, 2018

    Report

    Report Number
    3004962788-2018-00073
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 19, 2018
    Report Date
    January 2, 2019
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    JAK
    UDI-DI
    10884521199989
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A COMPONENT OF THE SUPERDIMENSION SYSTEM; CASE RECORDINGS, WERE RETURNED AND EVALUATED. ACCORDING TO PROCEDURE RECORDING VIDEO THE NAVIGATION CATHETER WAS NOT EXTENDED OUT OF THE BRONCHOSCOPE AS REQUIRED DURING PARTS OF THE REGISTRATIONS (DURING BOTH REGISTRATION ATTEMPTS). THIS CAUSED ELECTROMAGNETIC INTERFERENCE THAT LED TO EXCESSIVE CT-TO-BODY DIVERGENCE IN ALL LOBES, INCLUDING THE TARGET LOBE. DURING VERIFICATION SOME DISCREPANCY BETWEEN THE CT AND THE BRONCHOSCOPE VIEW WAS OBSERVED, NAVIGATION WAS PERFORMED AFTER VERIFICATION. PATIENT SENSORS MOVEMENT ANALYSIS REVEALS UNUSUAL MOVEMENT DURING THE FIRST REGISTRATION WHICH CAN FURTHER AFFECT THE REGISTRATION. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A COMPONENT OF THE SYSTEM, CASE RECORDINGS HAVE BEEN RECEIVED AND ARE CURRENTLY UNDER EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PHYSICIAN HAD DIFFICULTIES WITH REGISTRATION AND NAVIGATION WHILE THE NEW C-ARM WAS IN THE OPERATING ROOM. ONCE THEY REMOVED THE C-ARM FROM THE ROOM THE ISSUE WAS RESOLVED. THE PHYSICIAN HAD CANCELLED THE PROCEDURE AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO PATIENT INJURY. OUT OF AN ABUNDANCE OF CAUTION, SUPERDIMENSION IS FILING THIS MDR DUE TO THE ADDITIONAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001883 SUPERDIMENSION SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK COVIDIEN LP - SUPERDIMENSION INC AAS00161-20 10884521199989

    Patients

    Seq Age Sex Outcome Treatment
    1 Other