BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2922762 · Received January 18, 2013

    Report

    Report Number
    3004209178-2013-00768
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Report Date
    December 27, 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

    CATHETER MODEL 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, CATHETER MODEL 8780, SERIAL,# (B)(4), IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON HAD DIFFICULTY INSERTING CATHETER INTO CATHETER CONNECTOR. TWO DIFFERENT CONNECTORS WERE TRIED, BUT COULD NOT GET PASSED THE FIRST COLLET. IT WAS LATER REPORTED THAT AFTER THE SURGEON TRIMMED A PORTION OF CATHETER AND REINSERTED, HE WAS NOT ABLE TO GET THE CATHETER ALL THE WAY ON BUT HE WAS ABLE TO GET THE CATHETER PAST THE FIRST COLLET AND CONNECTED. THE SYSTEM WAS USED TO INFUSE BACLOFEN. NO INFORMATION WAS GIVEN REGARDING WHY THE SURGERY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27909 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1