BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1960947 · Received January 11, 2011

    Report

    Report Number
    6000030-2011-00245
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    January 1, 2005
    Report Date
    January 3, 2011
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED "HORRIBLE BOUTS OF WITHDRAWAL AND OVERDOSE". THE CATHETER WAS FOUND TO BE SHREDDED AND CRACKED AND WAS NOT CONNECTED TO THE PUMP. IT WAS ALSO NOTED THAT THE CATHETER HAD PREVIOUSLY KINKED AND TORN. A NEW CATHETER WAS IMPLANTED; THE OLD CATHETER WAS NOT REMOVED FROM THE PATIENT. IT WAS NOTED THAT THE PATIENT WAS IN A WHEELCHAIR. HE PUT A LOT OF WEAR AND TEAR ON THE CATHETER BECAUSE HE TWISTED, TURNED AND PRESSED AGAINST THE BACK OF THE SEAT. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 44 YR Required Intervention EXPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL #863740| IMPLANTED:| IMPLANTED:| LOT #NGV011782N| CATHETER: MODEL #8709, LOT# J12544R13| CATHETER: MODEL #8703W, LOT# L40242| IMPLANTED:| EXPLANTED: