BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANTA

    MDR report key: 17300728 · Received July 11, 2023

    Report

    Report Number
    3004209178-2023-12461
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Report Date
    August 3, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000411923
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 D10: PRODUCT ID: 748940. SERIAL# (B)(6). IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION. PRODUCT ID: 748940. SERIAL# (B)(6). IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION. PRODUCT ID: 3998. LOT#: V036810. IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD. PRODUCT ID 3778-60. SERIAL#: (B)(6). IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3998, SERIAL/LOT #: (B)(6), UBD: 18-MAY-2011, UDI#: (B)(4); PRODUCT ID: 3778-60, SERIAL/LOT #: (B)(6), UBD: (B)(6)2014, UDI#: (B)(4). 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

    A RESPONSE WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE STATING PATIENT HAD IMPEDANCES ON 10/11 RIGHT LEAD (8-15) COULD GET LD COVERAGE ON ONE LEG ONLY. DOCTOR TOOK X-RAYS AND CHECKED LEVELS OF PADDLE LEAD (NOT IN USE C6) AND LEVEL OF PERC LEAD (IN USE T10). DOCTOR REPORTS THAT HE WILL BE IN TOUCH WITH PRIOR SURGEON AND POSSIBLE LEAD REVISION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMPEDANCE WAS HIGH, 1: 19220 2: 34066 3: 30402 4-15: 40000. CANNOT PROVIDE DESIRED INTENSITIES BASED ON LIMITATIONS DUE TO HIGH IMPEDANCES. PATIENT HAD A RETURN OF PAIN. REP WORKING WITH PATIENT TO SCHEDULE AN APPT TO TAKE XRAY OF LEADS AND CHANGE REFERENCE ELECTRODE TO SEE IF ISSUE RESOLVES. WILL PROVIDE FOLLOW UP AFTER MEETING WITH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2255604 VANTA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 977006 00763000411923

    Patients

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