BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 10420492 · Received August 18, 2020

    Report

    Report Number
    3004209178-2020-14263
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 23, 2020
    Report Date
    August 18, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: PRODUCT ID 3487A-56 LOT# V884579 SERIAL# IMPLANTED: (B)(6) 2011,EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3888-45 LOT# V841063 SERIAL# IMPLANTED: (B)(6) 2011, EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3888-33 LOT# V861100 SERIAL# IMPLANTED: (B)(6) 2011, EXPLANTED: PRODUCT TYPE LEAD. 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

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE INDICATED THAT THE PATIENT¿S X-RAY HAS NOT BEEN COMPLETED, AND THE SERIAL NUMBERS OF THE LEADS ARE NOT KNOWN YET. THE REP NOTED THAT THE EVENT WAS NOT RESOLVED, AS THE PATIENT IS WAITING TO HAVE X-RAYS AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3487A-56, LOT#: V884579, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT#: V841063, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. PRODUCT ID: 3888-33, LOT#: V861100, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3487A-56, SERIAL/LOT #: (B)(4), UBD: 23-NOV-2015, PRODUCT ID: 3888-45, SERIAL/LOT #: (B)(4), UBD: 05-OCT-2015. PRODUCT ID: 3888-33, SERIAL/LOT #: (B)(4), UBD: 26-OCT-2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT. THE REP REPORTED THAT THEY WERE GETTING THE ¿SETTINGS NOT AVAILABLE¿ MESSAGE WHEN TRYING TO MAKE ADJUSTMENTS WITH THE PATIENT CONTROLLER. THEY STATED THAT THE PATIENT HAS BEEN EXPERIENCING THIS OVER THE PAST COUPLE OF WEEKS. THE REP STATED THAT THE PATIENT WAS PROGRAMMED WITH THE FOLLOWING PARAMETERS: A1 9+ 11- PW: 350US 40HZ A2 8+ 11- PW: 400US RATE:40HZ B1 8- 9- 11+ 4.9MA 300US RATE: 40HZ B2 8+ 9- 11+ AMP 3.3MA PW: 220US 40HZ. THEY MENTIONED THAT THE REP HAD AN ALERT ON THEIR TABLET THAT THE STIMULATION IS BELOW PROGRAMMED OUTPUT FOR GROUP A. TECHNICAL SERVICES HAD THE REP RUN IMPEDANCES AND THEY PROVIDED THE FOLLOWING VALUES: REF 11 8 16160OHMS 9 15930OHMS. THE REP INDICATED THAT THEY TRIED USING OTHER ELECTRODES WHICH CAUSED THE PATIENT TO FEEL PAINFUL STIMULATION SENSATIONS. THE REP MENTIONED THAT THE PHYSICIAN PLANS TO DO AN X-RAY AS THEY THINK THE LEADS MAY HAVE MOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884404 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR