BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3191378 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10934
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 11, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AROUND (B)(6) 2013 THE PATIENT NOTICED AN INCREASE IN SPASTICITY AND HAD A COMPUTERIZED TOMOGRAPHY (CT) SCAN TO RULE OUT A KIDNEY STONE. IT WAS NEGATIVE FOR KIDNEY STONE AND THE SPASTICITY CONTINUED. THE PATIENT DEVELOPED ITCHING APPROXIMATELY TWO WEEKS PRIOR TO THIS REPORT DATE. THE WEEK BEFORE THIS REPORT DATE, THE PATIENT HAD A SIGNIFICANT RETURN OF SPASMS. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS SEEN BY HER MANAGING PHYSICIAN. AN X-RAY AT THAT TIME SHOWED A COMPLETE BREAK IN THE CATHETER AT THE SPINAL ENTRY SITE. COINCIDENTALLY, THE PREVIOUS CT SCAN TO RULE OUT THE KIDNEY STONE WAS REVIEWED AND THE CATHETER WAS NOTED TO HAVE A BREAK BACK AT THAT TIME. THE PATIENT WAS PUT ON ORAL BACLOFEN, 10 MILLIGRAMS T.I.D. AND SCHEDULED THE REVISION ON (B)(6) 2013. AT THE REVISION, A COMPLETE BREAK IN THE CATHETER WAS FOUND. THE INTRATHECAL PIECE WAS UNABLE TO BE RETRIEVED EASILY AND THE PHYSICIAN LEFT IT IMPLANTED. THE REST OF THE CATHETER WAS COMPLETELY REMOVED AND A NEW CATHETER WAS IMPLANTED. THE EXPLANTED CATHETER PORTION WAS DISCARDED. THE PATIENT DOSE WAS CHANGED FROM 760 MICROGRAMS (MCG) PER DAY TO 380 MCG/DAY. THE PATIENT HAD A SCHEDULED APPOINTMENT FOR DOSE ADJUSTMENTS. THIS DEVICE SYSTEM WAS LISTED TO HAVE DELIVERED ¿BACLOFEN GABLOFEN.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE SYSTEM WAS USED TO INFUSELIORESAL. PATIENT OUTCOME NOTED AS RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291267 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention