BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VECTRIS SURESCAN

    MDR report key: 22123133 · Received June 2, 2025

    Report

    Report Number
    2649622-2025-14820
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 23, 2025
    Report Date
    July 17, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    LGW
    UDI-DI
    00763000708665
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G2: FOREIGN: CANADA. 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.

    Additional Manufacturer Narrative · 0

    H6: CODES UPDATED H3: THE LEAD MODEL 977A260, S/N (B)(6), WAS RETURNED FOR PRODUCT ANALYSIS. THE RETURNED DEVICE WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDE BUT IS NOT LIMITED TO VISUAL INSPECTION AND ELECTRICAL TESTING. ANALYSIS OF THE DEVICE FOUND A PROCEDURAL NO N-CONFORMANCE; THE STYLET COIL WAS PERFORATED BY THE STYLET. THE LEADS WERE SHIPPED WITH A BENT LEAD STYLET INSERTED, WHICH THE REPAIR TECHNICIAN NOTED INDICATES THAT THE PREVIOUS STYLET WAS REMOVED BEFORE A STRAIGHT TIP STYLET WAS INSERTED AND THUS THE BEND IN STYLET COIL OCCURRED WHILE IN USE. 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 MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE STYLET WOULD NOT FEED INTO THE LEAD. MULTIPLE ATTEMPTS TO CHANGE STYLET TO ADVANCE WITHOUT LUCK. NEW LEAD OPENED. THE ISSUE RESOLVED.

    Description of Event or Problem · 0

    SEE H11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10311 VECTRIS SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO VILLALBA 977A260 00763000708665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown