BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4248229 · Received November 13, 2014

    Report

    Report Number
    3004209178-2014-21501
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    October 23, 2014
    Report Date
    October 23, 2014
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8578, LOT # N143147, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, SERIAL # (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP CONNECTOR FOUND THE WHITE SILICONE BOOT TO BE OUT OF POSITION. THE DIFFICULTY ENCOUNTERED LED TO EXPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING A ROUTINE PUMP REPLACEMENT, THE PUMP CONNECTOR SEPARATED WHEN DISCONNECTION WAS ATTEMPTED. THE SILICONE SLEEVE SEPARATED FROM THE INNER METAL PORTION/RINGS OF THE CATHETER CONNECTOR. A NEW CONNECTOR WAS USED. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER MORPHINE AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732510 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR