BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3871827 · Received June 13, 2014

    Report

    Report Number
    6000030-2014-00076
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 22, 2014
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED): (B)(6) 2003, EXPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS CHANGE IN THERAPY EFFECT. IT WAS NOTED THAT THE PATIENT HAD AN INFECTION. IT WAS NOTED THAT THE PATIENT HAD OTHER MEDICAL ISSUES UNRELATED TO THE MANUFACTURER DEVICE THERAPY AND HAD 11 SURGERIES IN THE LUMBAR AREA WHERE THE CATHETER HAD BEEN IMPLANTED. IT WAS NOTED THAT THESE SURGERIES OCCURRED PRIOR TO THE PATIENT¿S FIRST PUMP SYSTEM, SO THE HCP BELIEVED THAT THE LUMBAR TISSUE HAD BEEN COMPROMISED. IT WAS REPORTED THAT ON (B)(6) 2013, THE PUMP SYSTEM WAS IMPLANTED AS THEY CONFIRMED NO INFECTION WAS PRESENT. THEN ON (B)(6) 2003, THE WHOLE SYSTEM WAS REMOVED AGAIN DUE TO INFECTION IN THAT SAME AREA. IT WAS NOTED THAT THE PATIENT WOULD GO THROUGH WITHDRAWAL AND THEY WOULD MANAGE WITH ORAL BACLOFEN DURING THOSE TIMES. IT WAS NOTED THAT ON (B)(6) 2004 A NEW SYSTEM WAS PLACED. THE PUMP SYSTEM WAS DELIVERING BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350451 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR Required Intervention