BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2991083 · Received March 6, 2013

    Report

    Report Number
    3004209178-2013-03369
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT AN X-RAY WAS ORDERED TO DETERMINE IF THERE WAS A CATHETER PROBLEM. IT WAS DETERMINED THAT THERE WAS NO PROBLEM WITH THE CATHETER ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED THAT ON (B)(6) 2013, THE ¿LUMBAR SPINE CT WITH CONTRAST REPORT REVEALED THAT THE CATHETER TUBING ENTERED THE SPINAL CANAL AT THE L3-L4 LEVEL. NO DEFINITE AREA OF CONTRAST EXTRAVASATION FROM THE CATHETER TUBING WAS VISUALIZED. THERE WAS A SMALL AREA OF INCREASED DENSITY SURROUND THE CATHETER NEAR ITS ENTRY SITE TO THE SPINAL CANAL. CONTRAST FLOWED FREELY THROUGH THE CATHETER TUBING AND EXITED THE CATHETER TIP.¿ AFTER FURTHER REVIEW, THE CT OF THE LUMBAR SPINE WITH CONTRAST REVEALED A LEAK AT THE LEVEL OF THE LUMBOSACRAL FASCIA. THE THORACIC MYELOGRAM PERFORMED ON THE SAME DAY REVEALED NO DEFINITE AREA OF CONTRAST EXTRAVASATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT ON (B)(6) 2013, THE LUMBAR SPINE CT WITH CONTRAST REPORT REVEALED THAT THE CATHETER TUBING ENTERED THE SPINAL CANAL AT THE L3-L4 LEVEL. NO DEFINITE AREA OF CONTRAST EXTRAVASATION FROM THE CATHETER TUBING WAS VISUALIZED. THERE WAS A SMALL AREA OF INCREASED DENSITY SURROUND THE CATHETER NEAR ITS ENTRY SITE TO THE SPINAL CANAL. CONTRAST FLOWED FREELY THROUGH THE CATHETER TUBING AND EXITED THE CATHETER TIP. THE PATIENT RETURNED ON (B)(6) 2013 AND REPORTED SHE WAS DOING WELL AND STILL FELT THAT THE CURRENT BACLOFEN THERAPY WAS ADEQUATE. SHE FELT THAT, AFTER THE PUMP MYELOGRAM, THE THERAPY IMPROVED. THE PHYSICAL EXAM WAS STABLE AND NO CHANGES WERE MADE TO THE INTRATHECAL BACLOFEN DOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FAINTED DURING A REFILL PROCEDURE. OTHER PATIENT SYMPTOMS INCLUDED PALE SKIN, NAUSEA, EYES ROLLING BACK AND FORTH, AND UNRESPONSIVENESS TO HER NAME BEING CALLED. TWO DAYS PRIOR TO REPORT, AN X-RAY REVEALED A QUESTIONABLE AREA OF PATENCY IN THE CATHETER TUBING WHERE IT ENTERED BETWEEN THE SPINOUS PROCESSES. ADDITIONALLY, THE NEXT DAY, THE PATIENT WAS SCHEDULED FOR AN INTRATHECAL DYE STUDY UNDER FLUOROSCOPY WITH A CT SCAN TO FOLLOW. SIX DAYS LATER, IT WAS REPORTED THAT THE EVENT HAD RESOLVED WITHOUT SEQUELA, THOUGH THE DATE OF RESOLUTION WAS LISTED (B)(6) 2013. AT THE TIME OF REPORT, THIS DATE HAD NOT OCCURRED YET. THE DRUG USED IN THIS SYSTEM WAS LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95881 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Other