BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3700724 · Received March 26, 2014

    Report

    Report Number
    3004209178-2014-05064
    Event Type
    Injury
    Date Received
    March 26, 2014
    Report Date
    March 4, 2014
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8590-1, LOT# N242817, IMPLANTED: 2010 (B)(6); PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS OF THE CATHETER REVEALED THAT UNDER MICROSCOPIC INSPECTION, THE SEAL AT THE BOTTOM OF THE SC CUP APPEARED TO BE GREATLY PUSHED IN. SC CONNECTOR CORING-TEARS-CUTS IN SEAL WERE NOTED. THERE WAS NO EVIDENCE OF AN OFF-CENTERED INDENT IN THE SEAL MATERIAL INDICATING THE PUMP CONNECTOR WAS PROPERLY ALIGNED WITH THE ¿S¿ CONNECTOR. NO OCCLUSION WAS OBSERVED DURING PATENCY TESTING; HOWEVER, DURING PRESSURE TESTING, LEAKING WAS IMMEDIATELY SEEN COMING FROM THE AREA OF THE SC CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CATHETER OCCLUSION. IT WAS NOTED THAT THE HEALTH CARE PROVIDER (HCP) WAS UNABLE TO ASPIRATE THE CATHETER WITHOUT FLUOROSCOPY IN THE OFFICE ON 2014 (B)(6); HOWEVER, IT WAS ALSO NOTED THE DATE WAS UNKNOWN. THE PATIENT HAD SYMPTOMS OF PAIN. DURING THE REVISION PROCEDURE, THE PUMP POCKET WAS OPENED AND THE HCP WAS UNABLE TO ASPIRATE THE CATHETER. THE "SUTURELESS" WAS SCARRED INTO THE PUMP POUCH AND THE HCP REMOVED IT. THEY THEN OBSERVED CEREBROSPINAL FLUID (CSF) FROM THE CATHETER AND A NEW SUTURELESS CONNECTOR WAS PUT ON THE CATHETER AND CONNECTED TO THE PUMP. THE HCP THEN ASPIRATED THROUGH THE CATHETER ACCESS PORT (CAP) AND IT ASPIRATED WITH EASE. THE PATIENT DOSE WAS REDUCED TO 1MG/DAY FROM PREVIOUS DOSING WITH THE PATIENT THERAPY MANAGER (PTM) AT 0.5 MG 6 TIMES A DAY OR EVERY 4H. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE PATIENT STATUS AT THE TIME OF THE EVENT WAS NOTED AS ¿ALIVE NO INJURY¿. THE PUMP SYSTEM WAS BEING USED TO DELIVER MORPHINE, BUPIVACAINE AND CLONIDINE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HAVING ISSUES AND THE PATIENT WAS REFERRED TO ANOTHER PHYSICIAN WHO DETERMINED THE CATHETER HAD BECOME TANGLED AND CAME ¿UNDONE¿, THEREFORE THE PATIENT HAD A REVISION. IT WAS AGAIN NOTED THE PHYSICIAN LOWERED THE DOSE AS THEY WERE NOT SURE HOW LONG THE PATIENT HAD NOT BEEN RECEIVING THE CORRECT DOSE. THE REPORTER STATED THIS ISSUE STARTED LAST MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178082 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention