BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-LOC 90

    MDR report key: 20725504 · Received November 19, 2024

    Report

    Report Number
    1219930-2024-05451
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    November 5, 2024
    Report Date
    November 19, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    UDI-DI
    20884521131610
    PMA / PMN Number
    K100257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT MEDICAL PRODUCT: VLOCM0004, VLOCM0004 V-LOC* 90 3-0 CLR 15CM P12X12 (LOT# A4G1733VFY), VLOCM0004, VLOCM0004 V-LOC* 90 3-0 CLR 15CM P12X12 (LOT# A4G1733VFY). 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

    ACCORDING TO THE REPORTER, DURING A PERMANENT PACEMAKER INSERTION PROCEDURE, THREE SUTURES OPENED, AND ALL THREE BROKE WHILE SUTURING. WITH THE FOURTH SUTURE, THE NEEDLE DID NOT BREAK OFF. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070522 V-LOC 90 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN VLOCM0004 A4G1733VFY 20884521131610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown