BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATION SYSTEM

    MDR report key: 1211055 · Received October 24, 2008

    Report

    Report Number
    2182207-2008-06863
    Event Type
    Injury
    Date Received
    October 24, 2008
    Report Date
    September 30, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: VODAPALLY MS, THIMINEUR MA, MASTROIANNI PP. TENSION PSEUDOMENINGOCELE ASSOCIATED WITH RETAINED INTRATHECAL CATHETER: A CASE REPORT WITH A REVIEW OF LITERATURE. PAIN PHYSICIAN. 2008; 11(3):355-362. WE REPORT A DETAILED CASE OF TENSION PSEUDOMENINGOCELE IN AN ADULT PATIENT DUE TO A BROKEN AND RETAINED LUMBAR INTRATHECAL CATHETER. IT IS ESSENTIAL TO BE AWARE OF THIS RARE COMPLICATION AND WE RECOMMEND APPROPRIATE NEUROSURGICAL INVOLVEMENT IN THE MANAGEMENT OF PSEUDOMENINGOCELE TO AVOID POTENTIAL AND CATASTROPHIC COMPLICATIONS. PSEUDOMENINGOCELE IS THE EXTRADURAL COLLECTION OF CSF DUE TO A BREACH IN THE DURAL-ARACHNOID LAYER AND THEY OCCUR AFTER INCIDENTAL DUROTOMY DURING LUMBAR SPINE SURGERY. REPORTABLE EVENT: PATIENT, MALE, HAD SPINAL CORD STIMULATOR IMPLANTED FOR PAIN. ONE YEAR LATER, THE SYSTEM WAS EXPLANTED FOR INADEQUATE PAIN CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATION SYSTEM LGW MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other PROGRAMMER: MODEL UNK N=1| LEAD: MODEL UNK N=1