BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1822603 · Received August 27, 2010

    Report

    Report Number
    6000030-2010-06536
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 29, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED DUE TO CHANGE IN INSURANCE PATIENT WAS TITRATED DOWN FROM 24MG/DAY OF DILAUDID, CLONIDINE, BUPIVICAINE AT 60MG/ML CONCENTRATION DOWN TO ABOUT 2 MG/DAY. PATIENT PUMP WAS NOT REFILLED SINCE (B)(6) 2009. PUMP WAS INTERROGATED AND NO ALARMS SHOWED. IT WAS LATER REPORTED PATIENT COMPLAINED OF INCREASED PAIN IN AFFECTED AREAS. A CATHETER DYE STUDY WAS DONE WHICH REVEALED MIGRATION OF CATHETER TIP INTO LUMBAR INTRASPINAL SPACE. IT WAS NOTED THERE WAS NO PROBLEM WITH PUMP ALTHOUGH BELIEVED IT WAS A SYNCHROMED EXTENDED LIFE AND NEARED END OF SERVICE (EOS). IT WAS STATED PUMP WAS EXPLANTED. PHYSICIAN REASSESSED PATIENT'S PAIN MANAGEMENT WITH ORAL MEDICATIONS/OTHER MODALITIES INITIALLY, AND WILL REVISIT INTRATHECAL PUMP THERAPY IF ORAL PRESCRIPTION MANAGEMENT DOES NOT PROVIDE ADEQUATE PAIN RELIEF. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention CATHETER: MODEL 8709, LOT# J11545R23| IMPLANTED:| EXPLANTED: