BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2810620 · Received October 31, 2012

    Report

    Report Number
    3004209178-2012-09777
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER, PRODUCT ID 8703W, LOT# L47430, IMPLANTED: 1998 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. FOR USE BY USER FACILITY/IMPORTER (DEVICES ONLY). (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR WAS UNABLE TO ASPIRATE THE CATHETER. THE CATHETER WAS COMPLETELY OCCLUDED. THE CATHETER WAS REPLACED AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention