BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENDA

    MDR report key: 21021567 · Received December 26, 2024

    Report

    Report Number
    3004209178-2024-24147
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    September 10, 2024
    Report Date
    December 26, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 8785 LOT# SERIAL# UNKNOWN PRODUCT TYPE CATHETER THE MODEL 8781 CATHETER WAS RETURNED IN THREE SEGMENTS WHICH INCLUDED THE SUTURE-LESS CONNECTOR ASSEMBLY, PIN CONNECTOR, AND GUIDEWIRE. ANALYSIS OF THE MODEL 8781 CATHETER IDENTIFIED THAT THE GUIDEWIRE HAD BEN BENT IN MULTIPLE PLACES. ANALYSIS OF THE MODEL 8785 CATHETER REVEALED NO ANOMALY. 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

    ON 2024-SEP-10 MPXR 1220782 (FOR, REP, HCP): INFORMATION WAS INITIALLY RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) ON 2024-SEP-10 REGARDING A PATIENT RECEIVING GABLOFEN (2000MCG/ML, 200 MCG/DAY) VIA IMPLANTED INFUSION PUMP. IT WAS REPORTED THAT THE ANCHOR WAS DAMAGED IN ONE OF THE WINGS. THE HCP REPORTED THAT THE WING HAD ALREADY BEEN CUT IN HALF. NO TROUBLESHOOTING WAS PERFORMED. THE ANCHOR REMAINED IN THE PATIENT AND THE HCP ATTEMPTED TO FIX IT AS BEST THEY COULD. THE ISSUE RESOLVED. THE PATIENT'S AGE, WEIGHT, AND MEDICAL HISTORY WERE ASKED, BUT WOULD NOT BE MADE AVAILABLE. THE PATIENT'S STATUS WAS ALIVE NO INJURY. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE ON 2024-SEP-11. IT WAS DURING THE INITIAL IMPLANT PROCEDURE THAT THE CATHETER ANCHOR WAS NOTED TO BE BROKEN. THE CAUSE OF THE BROKEN ANCHOR WAS NOT DETERMINED BUT IT SEEMED IT WAS LIKE THIS ORIGINALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2494546 ASCENDA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8781 0229159754

    Patients

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