BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3874494 · Received June 16, 2014

    Report

    Report Number
    3004209178-2014-11627
    Event Type
    Injury
    Date Received
    June 16, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH WHAT APPEARED TO BE AN INFECTED PUMP. THE PUMP AND CATHETER WERE REMOVED DUE TO INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE DEVICE SYSTEM WAS DELIVERING BACLOFEN. IT WAS LATER REPORTED THAT THE PUMP POCKET WAS NOTED TO BE INDURATED AND ERYTHEMATOUS. A CT SCAN DEMONSTRATED ABSCESS FORMATION. PUS WAS FOUND IN THE PUMP POCKET. THE PUMP AND PROXIMAL CATHETER WERE REMOVED; THE INTRATHECAL CATHETER WAS LEFT IN PLACE; A HEMOVAC DRAIN WAS INSERTED; THE PUMP POCKET WAS IRRIGATED WITH ANTIBIOTIC SOLUTION; THE INCISIONS WERE CLOSED; AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. CULTURES WERE SENT TO THE LAB OF THE PUMP POCKET PUS, THE PROXIMAL CATHETER FLUID, AND CSF (CEREBROSPINAL FLUID) FROM THE LUMBAR INTRATHECAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352504 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R