BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1910462 · Received November 18, 2010

    Report

    Report Number
    6000030-2010-09757
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    July 1, 2010
    Report Date
    November 12, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    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 PUMP WAS LOCATED IN THE ABDOMEN AND WAS LOOSE IN THE POCKET. THE PUMP WAS REPLACED. THE PT WAS LAST SEEN ON (B)(6) 2010; HE HAD SOME BILATERAL MUSCLE PAIN, BUT HE WAS FEELING PRETTY GOOD. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.

    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 65 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709, LOT# J11210R42| EXPLANTED: