BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1930030 · Received November 18, 2010

    Report

    Report Number
    6000030-2010-09768
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    January 1, 2006
    Report Date
    November 15, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN 2006, A (B)(6) WAS DONE AND A CATHETER KINK WAS CONFIRMED. THE PT WAS REFERRED TO ANOTHER PHYSICIAN AND HAD NOT BEEN SEEN SINCE. THE REPORTER DID NOT KNOW IF THE CATHETER ISSUE WAS RESOLVED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE. SEE ALSO MFR'S REPORT # 3004209178201006444.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR EXPLANTED:| MODEL 863740, LOT#: NGV410417H| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP:| CATHETER: MODEL 8709, LOT#: J10938R42