BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1760492 · Received July 15, 2010

    Report

    Report Number
    3004209178-2010-05525
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 6, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ONE MONTH AFTER IMPLANT, IT WAS DISCOVERED THRU A DYE STUDY THAT THE NEWLY IMPLANTED CATHETER HAD MIGRATED OUT OF THE INTRATHECAL SPACE. THE CATHETER WAS REVISED ON (B)(6) 2010. AT THE TIME OF THE REVISION, THE PHYSICIAN WAS ABLE TO REMOVE THE OLD CATHETER SEGMENT; THE PHYSICIAN FELT THAT THE MASS HAD DECREASED IN SIZE ENOUGH THAT ENABLED HIM TO REMOVE THE OLD FRAGMENT (SEE MANUFACTURER'S REPORT # 3007566237-2010-04397). THE PT RECOVERED AND WAS "DOING WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention CATHETER: MODEL 8709, LOT# J11683R21| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863720| PROGRAMMER: MODEL 8835, LOT# NPG016326N I| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8578, LOT# N253753012| CATHETER: MODEL 8709, LOT# N255173004| IMPLANTED:| LOT# NGP006705N| IMPLANTED: