BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2931548 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01044
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    May 29, 2012
    Report Date
    May 29, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2380-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OCCLUSION IN THE CATHETER OCCURRED. IT WAS NOTED THAT THE PATIENT HAD A FUNCTIONAL DECLINE, "LOST HER ABILITY TO WALK FOR 2+ YEARS, SUBSEQUENTLY GAINED A LOT OF WEIGHT BECAUSE OF LACK OF EXERCISE," HAD WORSENED SPASTICITY, UNDERDOSE WITH ESCALATION OF DOSE, AND SHE WAS "PREVIOUSLY WELL MANAGED ON 70MCG/DAY." PATIENT DID GET "SOME" RELIEF FROM SPASTICITY WITH "LARGE" BOLUSES AND FLEX PROGRAM. TROUBLE SHOOTING INCLUDED REVIEWING PUMP LOGS, BLOUSING THE PUMP, PLAIN X-RAYS OF THE ABDOMEN AND SPINE, PUMP SIDE PORT (CAP) ACCESS FOLLOWED BY COMPUTED TOMOGRAPHY (CT) DYE STUDY OF SPINE AND ABDOMEN TO EVALUATE INTRATHECAL CATHETER CONNECTIVITY AND AN MRI TO EVALUATE THE CATHETER TIP FOR SIGNS ON POSSIBLE ARACHNOID SCARRING, NONE OF WHICH REVEALED ABNORMALITY. AN INDIUM STUDY WITH SUBSEQUENT CT 44 HOURS LATER SHOWED DRUG DEPOSITING IN THE POCKET, AND THERE WAS NO TRACER DEPARTURE FROM THE PUMP INTO THE CATHETER WHEN RUNNING AT BASAL RATE. A REVISION WAS DONE. DURING THE REVISION, THE SURGEON FOUND "YELLOW, GELATINOUS GOO" INSIDE THE SC CONNECTION. INFECTION CULTURE WAS NEGATIVE. THE 1.5 X 0.2 0.1 CM PIECE OF "SOFT TAN MATERIAL AKA "SCHMUTZ"" WAS CLOGGING THE PROXIMAL CATHETER SITE. MICROSCOPIC EVALUATION "SHOWED THE "SCHMUTZ" CONSISTED OF FIBRINOUS STRANDS OF FIBROFIBRINOUS CONNECTIVE TISSUE THAT WAS PAUCICELLULAR AND CONTAINED SCATTERED MONONUCLEAR INFLAMMATORY INFILTRATES AS WELL AS REFRACTILE FOREIGN MATTER. NO SIGNIFICANT ACUTE INFLAMMATION OR VEGETATIONS WERE SEEN." THE HEALTHCARE TEAM BASED ON CLINICAL PRESENTATION, "FEELS THE GOO WAS IN THE FLUID PATH-SOME CONTROL OF SYMPTOMS WITH BOLUSES, BUT NOT ENOUGH." THE PATIENT'S SYMPTOMS OF UNDERDOSING RESOLVED AFTER REPLACEMENT OF CATHETER CONNECTOR, SHE WAS NOTED AS ALIVE, NO INJURY, NO ADVERSE EVENT, "DOING MUCH BETTER," FUNCTION IMPROVED, WAS "APPROACHING PREVIOUS BASELINE," WAS WALKING, THINNER AND "NOTICEABLE HAPPIER." THE DEVICE SYSTEM WAS USED TO INFUSE BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36786 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention