BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1071282 · Received July 8, 2008

    Report

    Report Number
    6000030-2008-03839
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    February 16, 2005
    Report Date
    June 13, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1147-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MAGNETIC RESONANCE IMAGE (MRI) REVEALED A 10MM CARIOCAUDALLY BY 3MM ANTEROPOSTERIORLY RIGHT MARAMEDIAN DORSAL MENINGIOMA AT THE LEVEL OF T10-11 INTERSPACE WHICH MILDLY NARROWED THE THECAL SAC AT THIS LEVEL. THE MASS SHOWED MODERATE POST-CONTRAST ENHANCEMENT. THE PT OPTED TO MANGE THE FIBROMA CONSERVATIVELY BY REPOSITIONING, BUT NOT REMOVING THE CATHETER. A SECOND MRI AS PERFORMED SIX MONTHS LATER. AN ENHANCING MASS WAS AGAIN IDENTIFIED. THE APPEARANCE OF THE MASS WAS ESSENTIALLY UNCHANGED FROM THE PRIOR STUDY, ALTHOUGH THERE WAS IMPINGEMENT AND MILD DEFORMITY OF THE SPINAL CORD VISIBLE IN ASSOCIATION WITH THE MASS AS WELL AS A MILDLY INCREASED T2-WEIGHTED SIGNAL IN THE CORD SUSPICIOUS FOR DEVELOPING MYELOPATHY, WHICH WAS NOT EVIDENT ON THE PRIOR MRI. FOUR MONTHS LATER, A THIRD MRI WAS OBTAINED. THE MASS WAS AGAIN IDENTIFIED. THE LESION WAS APPROX 8MM IN THE GREATEST TRANSVERSE DIMENSION AND APPROX 1.5 CM IN LONGITUDINAL DIMENSION. IT APPEARED TO ENCOMPASS THE TIP OF THE CATHETER AND MOST LIKELY REPRESENTED A CATHETER TIP GRANULOMA. THE GRANULOMA PRODUCED SIGNIFICANT APPEARING CORD COMPRESSION WITH A SUGGESTION OF SOME ASSOCIATED CORD GLIOSIS AND MINIMAL PROMINENCE OF THE CENTRAL CANAL WITHIN THE CORD. AT THIS POINT, THE PT ALSO COMPLAINED OF A NUMB OR "DIFFERENT" SENSATION IN HIS RIGHT LEG AND HIGH EXTENDING DOWN TO ABOUT THE KNEE. THE PT REPORTED HE WAS ABLE TO WALK AND GET ABOUT WITHOUT MUCH TROUBLE. THERE WERE NO SPHINCTER PROBLEMS. THE PT DID EXHIBIT HYPERREFLEXIA WITH 3+ KNEE JERKS BILATERALLY AND THREE BEAT CLONUS AT THE ANKLES BILATERALLY WITH DOWNGOING TOES. AT THIS POINT, THE PT'S PUMP CONTAINED DILAUDID 25 MG/ML (NO DOSE WAS REPORTED). THE PT'S DISTAL CATHETER AND THE GRANULOMA WERE REMOVED. FOLLOWING CATHETER REMOVAL THE PT EXPERIENCED MINOR SWELLING AT THE CATHETER INCISION DUE TO A PROBABLE CEREBROSPINAL FLUID LEAK. THERE WAS SOME MINOR DRAINAGE NOTED, BUT NO FEVER. THE PT ALSO EXPERIENCED POST-OPERATIVE MENINGITIS FOLLOWING REMOVAL OF THE CATHETER (NO TREATMENT WAS REPORTED). AS A RESULT THE PT LOST APPROX 10 POUNDS. THE PT REPORTED HE WAS RECOVERING, BUT IT WAS SLOW. THE PT RECOVERED WITHOUT SEQUELA. THE PUMP AND REMAINING CATHETER WAS REMOVED APPROX 11 MONTHS LATER AT THE PT'S REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| EXPLANTED:| CATHETER: MODEL 8709, LOT# J0058133R| IMPLANTED: