BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURIAN

    MDR report key: 10279784 · Received July 15, 2020

    Report

    Report Number
    2182207-2020-00525
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 25, 2020
    Report Date
    October 2, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GXD
    UDI-DI
    00763000140809
    PMA / PMN Number
    K181864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS #(B)(6): ANALYSIS FOUND LIZ ON THE UI PCBA WAS LOOSE. 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: PRODUCT ID AG1000. 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

    2020-(B)(6), SNOW RTG0055209 (HCP, REP): INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A RADIOFREQUENCY ABLATION (RFA) SYSTEM. IT WAS REPORTED THAT THERE WAS A F07 RF BOARD HARDWARE FAILURE MESSAGE ON THE GENERATOR. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED. 2020-(B)(6), SNOW RTG0055209, E1 (REP): ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REP HAD THE HCP RESTART THE GENERATOR AGAIN. IT WAS REPORTED THAT WHILE THEY WERE IN EITHER THE SENSORY OR MOTOR TESTING MODES, EVERYTHING WAS FINE. WHEN THEY GOT TO THE ACTUAL ABLATION, THEY SAW THE F07 ERROR MESSAGE. THE ACCOUNT HAD A BACKUP GENERATOR AND SO THEY TRIED THE SAME THING WITH THAT AND THE SAME ISSUE OCCURRED WHILE IN THE PROCEDURE. THE HCP GOT FRUSTRATED, SO THEY KEPT THE GROUNDING PAD ON AND USED AND OLDER RFA SYSTEM FROM A COMPETITOR, AND EVERYTHING WORKED FINE. IT WAS REPORTED THAT THE HCP WANTED TO HAVE THE GENERATOR REPLACED. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED. 2020--(B)(6), E2 (REP): ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REP DIDN'T KNOW THE SERIAL NUMBER OF THE SECOND GENERATOR. IT WAS NOTED THAT THIS GENERATOR HAS BEEN WORKING PROPERLY AND WOULDNOT BE RETURNED FOR ANALYSIS. IT WAS NOTED THAT THE FIRST GENERATOR WAS RETURNED FOR ANALYSIS. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED. 2020--(B)(6), E3: IT WAS REPORTED THAT THE RMA # IS 2070293. **IT WAS DETERMINED THAT THIS GENERATOR WAS ALREADY ASSIGNED RMA # 2070202. THE ANALYSIS RESULTS HAVE BEEN ADDED**

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REP DIDN'T KNOW THE SERIAL NUMBER OF THE SECOND GENERATOR. IT WAS NOTED THAT THIS GENERATOR HAS BEEN WORKING PROPERLY AND WOULD NOT BE RETURNED FOR ANALYSIS. IT WAS NOTED THAT THE FIRST GENERATOR WAS RETURNED FOR ANALYSIS. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A RADIOFREQUENCY ABLATION (RFA) SYSTEM. IT WAS REPORTED THAT THERE WAS A F07 RF BOARD HARDWARE FAILURE MESSAGE ON THE GENERATOR. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED. ON 2020-JUN-26, (B)(6), (B)(4) (REP): ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REP HAD THE HCP RESTART THE GENERATOR AGAIN. IT WAS REPORTED THAT WHILE THEY WERE IN EITHER THE SENSORY OR MOTOR TESTING MODES, EVERYTHING WAS FINE. WHEN THEY GOT TO THE ACTUAL ABLATION, THEY SAW THE F07 ERROR MESSAGE. THE ACCOUNT HAD A BACKUP GENERATOR AND SO THEY TRIED THE SAME THING WITH THAT AND THE SAME ISSUE OCCURRED WHILE IN THE PROCEDURE. THE HCP GOT FRUSTRATED, SO THEY KEPT THE GROUNDING PAD ON AND USED AND OLDER RFA SYSTEM FROM A COMPETITOR, AND EVERYTHING WORKED FINE. IT WAS REPORTED THAT THE HCP WANTED TO HAVE THE GENERATOR REPLACED. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741047 ACCURIAN GENERATOR, LESION, RADIOFREQUENCY GXD MEDTRONIC NEUROMODULATION AG1000 00763000140809

    Patients

    Seq Age Sex Outcome Treatment
    1 "SEE H10...."