BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1082129 · Received July 24, 2008

    Report

    Report Number
    2182207-2008-04343
    Event Type
    Injury
    Date Received
    July 24, 2008
    Report Date
    June 26, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: CATHETER. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: RAMSEY C N, OWEN RD, WITT WO, GRIDER, JS. INTRATHECAL GRANULOMA IN A PT RECEIVING HIGH DOSE HYDROMORPHONE: PAIN PHYSICIAN 2008; 11:3:369-373. IN THE CURRENT CASE WE REPORT THE EVAL AND MANAGEMENT OF AN INTRATHECAL GRANULOMA IN A PT RECEIVING A RELATIVELY HIGH CONCENTRATION OF INTRATHECAL HYDROMORPHONE. THOUGH USE OF INTRATHECAL HYDROMORPHONE STILL REPRESENTS AN OFF LABEL APPLICATION, THIS OPIATE IS COMMONLY EMPLOYED AS AN ALTERNATIVE FIRST LINE ANALGESIC AGENT. RAPIDLY DECLINING NEUROLOGIC FUNCTION WITH A CONFIRMED INFLAMMATORY MASS ADHERENT TO THE SPINAL CANAL NECESSITATED URGENT SURGICAL INTERVENTION. REPORTABLE EVENT: WE PRESENT THE CASE OF A MALE WITH A HISTORY OF CHRONIC LUMBAR SPINE PAIN. THE PT HAD RECEIVED AN INTRATHECAL DRUG DELIVERY SYSTEM 8 YRS AGO. MORPHINE WAS THE INITIAL DRUG CHOSEN FOR THERAPY, HOWEVER APPROX 2 YRS AGO HE RECALLS BEING SWITCHED TO HYDROMORPHONE. HE WAS REFERRED TO OUR INSTITUTION FOR EVAL WITH INCREASING BACK PAIN AND GAIT INSTABILITY IN THE PRECEDING 4 WKS, AS WELL AS URINARY RETENTION AND WEAKNESS IN THE LOWER EXTREMITIES. A MRI AND CT SCAN REVEALED AN INTRADURAL-EXTRAMEDULLARY LESION. THE PT WAS TAKEN TO THE OR FOR DECOMPRESSIVE LAMINECTOMY AND EXPLORATION WHICH SHOWED A 1CM MASS ADHERENT TO THE SPINAL CORD, ADJACENT TO THE TIP OF THE INTRATHECAL CATHETER. ONCE THE LESION WAS DETERMINED TO BE AN INFLAMMATORY MASS, IT WAS CAREFULLY DISSECTED AWAY FROM THE SPINAL CORD. ALL CULTURES OF THE SPECIMENS WERE NEGATIVE AND THE PT WAS DISCHARGED HOME AFTER 2 DAYS WITH A STABLE BUT IMPROVING NEUROLOGIC EXAM. AT 4 MONTHS POSTOPERATIVELY, HE HAD PERSISTENT NUMBNESS IN HIS LOWER EXTREMITIES AND ELECTED TO HAVE THE IDDS REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R PROGRAMMER MODEL UNK N=1| CATHETER MODEL UNK N=1