BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALLEYLAB FT10

    MDR report key: 15919692 · Received December 5, 2022

    Report

    Report Number
    1717344-2022-01490
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    November 13, 2022
    Report Date
    April 7, 2023
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884521516328
    PMA / PMN Number
    K151649
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 60SF2, CRYO ACC 60SF2 CRYOCATH SURGIFROST (SERIAL#: (B)(4); R65CS1, CONSOLE R65CS1 CRYOFLEX (SERIAL#:(B)(4); 49341, CLAMP 49341 CARDIOBLATE LP FT (SERIAL#: (B)(4); (LOT#: 631E). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, PATIENT HAD A TACHYBRADYCARDIA. A SINUS RHYTHM WITH FIRST-DEGREE AV BLOCK FOR A PERIOD OF TIME WAS NOTED FOR A PERIOD OF TIME. THE PATIENT CONTINUED TO HAVE INTERMITTENT PERIODS OF JUNCTIONAL RHYTHM. EP WAS CONSULTED. PATIENT UNDERWENT A PERMANENT PACEMAKER MEDTRONIC DUAL-CHAMBER WITH LEFT BUNDLE BRANCH ARE PACING. THERE WERE NO INTRAPROCEDURAL COMPLICATIONS. SURGEON HAVE NOT SEEN SINUS NODE FUNCTION SINCE SURGERY. NOTED ON DAY 5 POST-OP. SINUS NODE WAS POSSIBLE INJURED DURING THE SURGERY. POSTOPERATIVELY, THE PATIENT HAD BEEN IN JUNCTIONAL RHYTHM RATE OF 40S TO 50S WITH OCCASIONAL RARE SINUS BEAT. ADVERSE EVENT POSSIBLY RELATED TO CONCOMITANT PROCEDURE AND STUDY DEVICE.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE PATIENT HAD SICK SINUS SYNDROME. A SINUS RHYTHM WITH FIRST-DEGREE AV BLOCK WAS NOTED FOR A PERIOD OF TIME. THE PATIENT CONTINUED TO HAVE INTERMITTENT PERIODS OF JUNCTIONAL RHYTHM. EP WAS CONSULTED. PATIENT UNDERWENT A PERMANENT PACEMAKER MEDTRONIC DUAL-CHAMBER WITH LEFT BUNDLE BRANCH ARE PACING. THERE WERE NO INTRAPROCEDURAL COMPLICATIONS. THE SURGEON HAS NOT SEEN SINUS NODE FUNCTION SINCE SURGERY. NOTED ON DAY 5 POST-OP. SINUS NODE WAS POSSIBLE INJURED DURING THE SURGERY. POSTOPERATIVELY, THE PATIENT HAD BEEN IN JUNCTIONAL RHYTHM RATE OF 40S TO 50S WITH OCCASIONAL RARE SINUS BEAT. ADVERSE EVENT POSSIBLY RELATED TO CONCOMITANT PROCEDURE, STUDY PROCEDURE AND STUDY DEVICE. THE PATIENT WAS RECOVERED/RESOLVED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2541823 VALLEYLAB FT10 ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER VLFT10GEN 10884521516328

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Hospitalization| R