BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2180948 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05680
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 5, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT AN INTRATHECAL BACLOFEN PUMP REPLACEMENT PROCEDURE IN FEBRUARY, IN WHICH A 20 CC PUMP WAS REPLACED WITH A 40 CC PUMP. SINCE THE REPLACEMENT PROCEDURE, THE PT HAD STRUGGLED WITH WOUND BREAKDOWN AND INFECTION AT THE PUMP SITE. THE PT HAS HAD "2-3 OTHER" OPERATING ROOM PROCEDURES PERFORMED IN AN ATTEMPT TO TREAT THE PROBLEM AND SALVAGE THE PUMP. THE PT'S PUMP WAS AGAIN REPLACED ON (B)(6) 2011 WITH ANOTHER 20CC PUMP. IT WAS INDICATED THAT NO SIGNS/SYMPTOMS OF WITHDRAWAL WERE EVER NOTED; AND NO TROUBLESHOOTING WAS DONE. IT WAS LATER REPORTED THAT THE PT WAS DISCHARGED FROM THE HOSPITAL. ACCORDING TO THE REPORTER, THERE WERE NO CURRENT ISSUES AND THE PT HAD RECOVERED. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J13109R01