BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 4390946 · Received January 7, 2015

    Report

    Report Number
    6000030-2015-00006
    Event Type
    Malfunction
    Date Received
    January 7, 2015
    Date of Event
    October 9, 2014
    Report Date
    December 10, 2014
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP AND CATHETER REPLACEMENT PROCEDURE WAS VERY DIFFICULT DUE TO OLD SCARRING AND DIFFICULTY OF THE PATIENT¿S OBESITY AND THORACIC SPINE. IN TERMS OF COMPLICATIONS, NONE WERE NOTED WITH THE PROCEDURE. NOTES WERE PROVIDED FROM THE PROCEDURE. AFTER DETERMINING THAT THE CATHETER WAS NONFUNCTIONAL (REFER TO MANUFACTURER REPORT # 6000030-2014-00153 FOR THE NONFUNCTIONAL CATHETER INFORMATION), THE PATIENT WAS PLACED ON HER SIDE AND THE INCISION IN THE ABDOMEN WAS CLOSED. THE SURGEON THEN MADE AN ATTEMPT TO ENTER THE THECAL SAC HOWEVER THE NEEDLE COULD NOT BE PLACED INTO THE THECAL SAC BECAUSE OF THE PATIENT¿S SEVERELY ARTHRITIC SPINE AND THE LARGE-BORE NEEDLE NEEDED TO ENTER THE CATHETER COULDN¿T BE ADVANCED. AT THAT POINT, THE SURGEON DEICED TO CLOSE THE SMALL OPENING IN THE PATIENT¿S SPINE AND THE PATIENT WAS REPOSITIONED IN A PRONE MANNER. IT WAS NOTED ALL PREVIOUS ATTEMPTS HAD BEEN DONE UNDER FLUOROSCOPIC GUIDANCE ALSO. THE PATIENT WAS POSITIONED PRONE AND THE INCISION WAS DEEPENED TO AND THROUGH THE FASCIA TO THE LAMINA, AND THE LAMINA WAS OPENED. THE NEEDLE WAS PLACED THROUGH THE INTRALAMINAR SPACE INTO THE THECAL SAC. FREE FLOW OF CEREBROSPINAL FLUID (CSF) WAS OBTAINED, AND THE INTRATHECAL CATHETER WAS ADVANCED UP TO THE T10 LEVEL, AND THE STYLED WAS REMOVED. GOOD FLOW OF CSF WAS OBTAINED. AFTER PLACEMENT OF THE NEW CATHETER, THE PATIENT¿S PREVIOUS PUMP WAS THEN REMOVED (REFER TO MANUFACTURER REPORT # 6000030-2014-00153 FOR THE REASON FOR PUMP REMOVAL). IT WAS LASTLY NOTED THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE RECOVERY ROOM IN STABLE CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED INCLUDING DRUG INFORMATION AND HOW THE PATIENT WAS NOW DOING AND BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10750 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR