BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN & SHURTLEFF

    MDR report key: 21901591 · Received April 24, 2025

    Report

    Report Number
    3015537318-2025-00044
    Event Type
    Injury
    Date Received
    April 24, 2025
    Report Date
    April 24, 2025
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    LKK
    UDI-DI
    01088670403591
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTERA 3000 (FORMERLY CODMAN 3000) SPECIFIES INFECTION AS A KNOWN ADVERSE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    DURING THE LITERATURE REVIEW FOR THE 2024 ANNUAL REPORT, THE FOLLOWING CITATION WAS REVIEWED: RECURRENCE PATTERNS AFTER COMPLEX MULTIMODALITY THERAPY AND HEPATIC ARTERIAL INFUSION FOR COLORECTAL LIVER METASTASES: A REFLECTION OF BIOLOGY AND TECHNIQUE. HERNANDEZ MC, FAN D, SANDHU J, MAHURON K, KESSLER J, RAOOF M, FAKIH M, SINGH G, FONG Y, MELSTROM LG.J SURG ONCOL. 2024 JUN;129(7):1254-1264. DOI: 10.1002/JSO.27622. EPUB 2024 MAR 20.PMID: 38505908. PLEASE NOTE THAT THE DATES OF THE STUDY WERE FROM 2017-2021, SO THE DEVICES LIKELY INCLUDED WERE THE CODMAN 3000 AND/OR THE MEDTRONIC SYNCHROMED WITH THE CODMAN TAPERED CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289293 CODMAN & SHURTLEFF IMPLANTABLE DRUG DELIVERY PUMP LKK CODMAN & SHURTLEFF AP-03000H 01088670403591

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention