BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 21942296 · Received May 1, 2025

    Report

    Report Number
    3004209178-2025-07534
    Event Type
    Injury
    Date Received
    May 1, 2025
    Report Date
    May 1, 2025
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS NOT KNOWN. PLEASE SEE B5 FOR APPROXIMATE DATE RANGE, IF APPLICABLE. SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME VECTRIS SURESCAN; PRODUCT ID 977A260 (SERIAL: (B)(6)); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE 2019-08-13; EXPLANT DATE 2025-04-28 BRAND NAME VECTRIS SURESCAN; PRODUCT ID 977A260 (SERIAL: (B)(6)); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2019; EXPLANT DATE (B)(6) 2025. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). REP REPORTED THAT THE LEADS MIGRATED DOWN FROM THEIR ORIGINAL PLACEMENT, CAUSING THEM TO HAVE LESS BACK RELIEF. NEW LEADS AND INS WERE IMPLANTED AND PLACED HIGHER AND ANCHORED SECURELY. THE DEVICES HAVE BEEN DISCARDED AND THE ISSUE HAS BEEN RE SOLVED. REP INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195080 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

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