BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1211057 · Received October 24, 2008

    Report

    Report Number
    2182207-2008-06868
    Event Type
    Injury
    Date Received
    October 24, 2008
    Report Date
    September 30, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - CATHETER.

    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: FOUR MONTHS LATER, THE PATIENT UNDERWENT ANOTHER IMPLANT OF ANOTHER INTRATHECAL CATHETER AND SYNCHROMED II PROGRAMMABLE PUMP. SEVEN WEEKS LATER, HE DEVELOPED A CYSTIC SWELLING IN THE LUMBAR AREA. A PERICATHETER CSF LEAK WAS CONFIRMED AND FIXED WITH PURSE STRING SUTURES. THE LEAK CONTINUED AND A DIAGNOSIS OF CSF FISTULA WITH TENSION PSEUDOMENINGOCELE WAS MADE. THE PUMP AND THE CATHETERS WERE REMOVED FOLLOWED BY DUROPLASTY. THE CSF LEAK CONTINUED AND 2 DAYS POST AN INTERNALIZED LUMBOPERITONEAL SHUNT WAS PLACED. PATIENT IS CURRENTLY MANAGING PAIN WITH ORAL OPOID MEDICATION. SEE MFR REPORT #2182207-2008-06863.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R CATHETER: MODEL UNK N=1| PROGRAMMER: MODEL UNK N=1