BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2873867 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11840
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT # J0039928R, IMPLANTED: (B)(6) 2000, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PUMP REPLACEMENT SCHEDULED FOR (B)(6) 2012. DURING THE PROCEDURE, THE CATHETER COULD NOT BE ASPIRATED. AN X-RAY SHOWED THE CATHETER HAD DISLODGED FROM THE INTRATHECAL SPACE. THE SURGEON BELIEVED THIS WAS FROM A SPINE SURGERY THE PATIENT HAD APPROXIMATELY SIX MONTHS PRIOR TO THE REPORT THAT WAS PERFORMED BY A DIFFERENT SURGEON. THE SURGEON ATTEMPTED TO IMPLANT A NEW CATHETER BUT WAS UNSUCCESSFUL. THE PATIENT HAD BEEN FUSED SINCE HER LAST PUMP REPLACEMENT AND THE SPINE WAS "VERY TOUGH" AND THEREFORE, THE SURGEON WAS UNABLE TO EASILY ACCESS THE INTRATHECAL SPACE. IT WAS DECIDED TO EXPLANT THE ENTIRE DEVICE SYSTEM AND NOT REPLACE. THERE WERE NO PATIENT SYMPTOMS OR INJURY RELATED TO THIS EVENT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS NO INJURY OR ADVERSE EVENT. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL (BACLOFEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR