BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1071283 · Received July 8, 2008

    Report

    Report Number
    6000030-2008-03845
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    October 18, 2007
    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

    A X-RAY (2006) REVEALED NO PARASPINAL MASSES WERE PRESENT, AND A CATHETER WAS NOTED AT T9-10 LEVEL. A YEAR AND TWO MONTHS LATER A MAGNETIC RESONANCE IMAGE (MRI) WAS PERFORMED (2007) WHICH REVEALED ON THE SAGITTAL T2-WEIGHTED IMAGES THE SUGGESTION OF A LINEAR STRUCTURE, POSSIBLY THE CATHETER EXTENDING UPWARD IN THE VENTRAL ASPECT OF THE THECAL SAC UP TO APPROX THE T9 LEVEL. AT THIS LEVEL, AN INTRADURAL EXTRAMEDULLARY SOFT-TISSUE SIGNAL INTENSITY MASS WAS PRESENT IN THE VENTRAL ASPECT OF THE CANAL, VENTRAL TO THE SPINAL CORD. THE MASS MEASURES APPROX 8MM IN DIAMETER. THERE WAS SIGNIFICANT COMPRESSION OF THE SPINAL CORD AT THAT LEVEL, AND APPEARED TO BE SOME ABNORMALLY INCREASED T2-WEIGHTED SIGNAL PRESENT WITHIN THE SPINAL CORD AT THIS LEVEL, POSSIBLY RELATED TO SOME COMPRESSIVE MYELOMALACIA. THE IMAGES WERE CONSISTENT WITH A "CATHETER TIP FIBROMA". OPTIONS WERE DISCUSSED WITH THE PT. AT THE TIME OF THE DIAGNOSIS, THE PT'S PUMP CONTAINED MORPHINE 50 MG/ML (NO DOSE WAS REPORTED). THE PT WAS CONTINUED ON THIS CONCENTRATION THROUGH THEIR LAST REFILL (2008). THE PT'S LOW BATTERY ALARM THEN SOUNDED. THE PT'S PUMP WAS FILLED WITH PRESERVATIVE FREE NORMAL SALINE AND RUN AT MINIMUM RATE UNTIL A DECISION WAS MADE REGARDING COURSE OF CARE WITH THE GRANULOMA. THE PT COULD STILL WALK, BUT WAS WEAK. THERE WAS NO LOSS OF BOWEL OR BLADDER CONTROL. NO ADD'L PT TREATMENT OR OUTCOME WAS REPORTED.

    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 76 YR Required Intervention PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| IMPLANTED| EXPLANTED| CATHETER: MODEL 8709, LOT# L68734