BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1910610 · Received November 19, 2010

    Report

    Report Number
    6000030-2010-09818
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    May 12, 2004
    Report Date
    November 18, 2010
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED INCREASED PAIN. THERE WAS NO RESPONSE DESPITE MULTIPLE ADJUSTMENTS TO THE PUMP. THERE WAS A SURGICAL INTERVENTION OF THE INTRATHECAL PORTION OF THE CATHETER ON (B)(6) 2004. PT'S OUTCOME WAS NOT REPORTED. PUMP MEDICATION WAS NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11719R23| CATHETER: MODEL 8709, LOT# J11787R11| EXPLANTED:| IMPLANTED: