BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LRS INSTANT DETACHER

    MDR report key: 19259768 · Received May 7, 2024

    Report

    Report Number
    2029214-2024-00870
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    April 3, 2024
    Report Date
    July 24, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    HCG
    UDI-DI
    00763000290702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE H.6. CODES HAVE BEEN UPDATED TO REFLECT THE NEW INFORMATION IN THE MDR. PLEASE REFER TO REGULATORY REPORT 2029214-2024-01066 FOR FURTHER INFORMATION REGARDING THIS EVENT. 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

    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

    EVENT DETERMINED TO BE A DUPLICATE OF ANOTHER REPORTED EVENT.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT AN INSTANT DETACHER WAS USED TO DEPLOY AN AXIUM COIL. WHEN ATTEMPTING TO REMOVE THE DETACHER, IT WOULD NOT FULLY RELEASE FROM THE BACK END OF THE COIL SHAFT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381029 LRS INSTANT DETACHER DEVICE, NEUROVASCULAR EMBOLIZATION HCG MICRO THERAPEUTICS, INC. DBA EV3 ID-1-5 B677789 00763000290702

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown