BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2951361 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01513
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4). FINAL ANALYSIS OF THE PUMP FOUND NO ANOMALIES. FINAL ANALYSIS OF THE CATHETER FOUND NO SIGNIFICANT ANOMALIES, THOUGH IT HAD BEEN DAMAGED AT EXPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP AND CATHETER WERE EXPLANTED DUE TO A POSSIBLE INFECTION, BUT NOT REPLACED. IT WAS ALSO NOTED THAT THE PUMP HAD NOT BEEN RELIEVING THE PATIENT'S 'ISSUES' AND THE PATIENT WAS NOT 'SATISFIED' WITH THE PUMP. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY RELATED TO THE EVENT. THE DRUG USED IN THIS SYSTEM WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56862 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention