BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1211056 · Received October 24, 2008

    Report

    Report Number
    2182207-2008-06865
    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
    Product Problem
    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: THREE MONTHS AFTER THE SYNCHROMED II IMPLANT WITH THE ORIGINAL CATHETER OF FIVE YEARS, THERE WAS INADEQUATE PAIN RELIEF. SURGICAL EXPLORATION FOUND THE SPINAL END OF THE CATHETER BROKEN AND ANCHORED IN THE PARA SPINAL MUSCLE TISSUE. THE CATHETER COULD NOT BE RETRIEVED. THE PUMP WAS PLACED BACK IN THE ORIGINAL POCKET WITH A PLAN TO IMPLANT A CATHETER AT A LATER DATE. TWENTY SIX DAYS LATER, THE PATIENT PRESENTED WITH WOUND DISCHARGE, SWELLING AND A PARTIALLY EXPOSED PUMP THAT REQUIRED EMERGENCY REMOVAL. 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 Required Intervention PROGRAMMER: MODEL UNK N=1| CATHETER: MODEL UNK N=1