BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 15814137 · Received November 17, 2022

    Report

    Report Number
    3004209178-2022-15135
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Report Date
    November 16, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3887-45, LOT#: (B)(4) SERIAL#:, IMPLANTED: ON (B)(6) 2011, EXPLANTED:, PRODUCT TYPE: LEAD, PRODUCT ID: 3708260, LOT#: SERIAL#: (B)(4), IMPLANTED: ON (B)(6) 2011, EXPLANTED:, PRODUCT TYPE: EXTENSION, PRODUCT ID: 3887-45, LOT#: (B)(4) SERIAL#:, IMPLANTED: ON (B)(6) 2011, EXPLANTED:, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3887-45, SERIAL/LOT #: (B)(4), UBD: 24-SEP-2011, UDI#: (B)(4) ; PRODUCT ID: 3887-45, SERIAL/LOT #: (B)(4), UBD: 25-AUG-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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT LOW IMPEDANCE AND HIGH IMPEDANCE. CONNECTION CHECK SHOWED RED X AT ELECTRODE 1. IMPEDANCE CHECK SHOWS RED X >40000 AT ELECTRODE 1 ELECTRODE 2: 20350 ELECTRODE 5: 31160 ELECTRODE 6: 14000 ELECTRODE 7: 34710 ELECTRODE 15: 7150. PATIENT HAD INTERMITTENT STIMULATION. PT STATES ALL PAINFUL AREAS COVERED BY PROGRAM A. DIARY SHOWS A USED 100% OF TIME. ISSUE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192630 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 Male