BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3901728 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12251
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE CATHETER. (B)(4). ANALYSIS OF THE PUMP REVEALED NO ANOMALY. ANALYSIS OF THE CATHETER REVEALED THAT DIFFICULTY WITH THE SUTURELESS CONNECTOR LED TO THE EXPLANT. WHILE ATTACHED TO THE PUMP, THE CATHETER SHOWED TO BE POSSIBLY OCCLUDED. ONCE THE CATHETER WAS CUT ONE INCH FROM THE CONNECTOR, IT SHOWED TO BE PATENT. THE PIN CONNECTOR WAS TESTED AND FOUND TO BE OCCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IT WAS REPORTED THAT, DURING A PUMP REPLACEMENT ON THE REPORT DATE, THE PHYSICIAN WAS UNABLE TO REMOVE THE EXISTING SUTURELESS CONNECTOR, SO HE REPLACED THE CONNECTOR. THE CATHETER REMAINED IMPLANTED. A NEW CATHETER WAS ATTACHED. IT WAS NOTED THAT THE MANAGING PHYSICIAN EXPECTED NO PROBLEMS WITH THE PREVIOUS CATHETER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS INDICATED TO BE ¿ALIVE-NO INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379411 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR