BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 20598269 · Received November 4, 2024

    Report

    Report Number
    3004209178-2024-21425
    Event Type
    Injury
    Date Received
    November 4, 2024
    Report Date
    November 4, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315474
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A260, SERIAL/LOT #: (B)(6), UBD: 10-APR-2027, UDI#: (B)(4) MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THERE WAS AN IMPEDANCE ISSUE, ELECTRODES: 11: 30700 12: 30490 13: 23230.  A LOSS OF STIMULATION WAS NOTED. PATIENT DENIES FALLS, TRIPS OR ACCIDENTS. PATIENT STATES THAT HE DOES SLEEP ON A SLEEP NUMBER BED AND IS CONCERNED THAT THAT MIGHT HAVE AFFECTED IT. PROVIDER UPDATED. PLAN IS TO SCHEDULE LEAD REVISION ONCE OFFICE RECEIVES PRE AUTHORIZATION. THE ISSUE IS ONGOING. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789557 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97716 00763000315474

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention "SEE H11...."