BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 2140961 · Received June 21, 2011

    Report

    Report Number
    3007566237-2011-04640
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    January 1, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENT REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: RUAN X, LIU H, COUCH JP, WANG F, CHIRAVURI S. RECURRENT CELLULITIS ASSOCIATED WITH LONG-TERM INTRATHECAL OPIOID INFUSION THERAPY: A CASE REPORT AND REVIEW OF THE LITERATURE. PAIN MEDICINE. 2010;11(6):972-976. SUMMARY: THE AUTHORS PRESENT A CASE OF RECURRENT CELLULITIS IN AN ELDERLY LADY WITH PERSISTENT LEG EDEMA ASSOCIATED WITH INTRATHECAL MORPHINE/HYDROMORPHONE INFUSION THERAPY. EVENT: THE AUTHORS REPORT ON A (B)(6) FEMALE, WITH INTRACTABLE CHRONIC LOW BACK PAIN AND BILATERAL LEG PAIN TREATED WITH AN INTRATHECAL INFUSION OF MORPHINE UP TO 5 MG/DAY OVER 3 MONTHS WITH SATISFACTORY PAIN CONTROL DEVELOPED PROGRESSIVE LOWER EXTREMITY EDEMA, COMPLICATED BY RECURRENT CELLULITIS WITH FEVER, REQUIRING REPEATED HOSPITALIZATION AND INTRAVENOUS ANTIBIOTIC TREATMENT. SWITCHING TO INTRATHECAL HYDROMORPHONE HELPED MINIMALLY. INTRATHECAL BACLOFEN AND CLONIDINE INFUSION RESULTED IN COMPLETE RESOLUTION OF LEG EDEMA AND PAIN RELIEF OVER THE FOLLOWING 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention CATHETER UNKNOWN