BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4221957 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20879
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 15, 2014
    Report Date
    November 5, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, LOT# N171026012, IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS INDICATED THAT THE PATIENT WAS UNDERGOING A ROUTINE PUMP REPLACEMENT DUE TO A NORMAL ERI (ELECTIVE REPLACEMENT INDICATOR). BEFORE DISCONNECTING THE CATHETER FROM THE PUMP, THE HEALTHCARE PROVIDER (HCP) ATTEMPTED TO ASPIRATE THROUGH THE CATHETER ACCESS PORT (CAP); HOWEVER, HE WAS UNABLE TO GET CSF (CEREBROSPINAL FLUID) BACK. THE HCP THEN RELEASED THE TISSUE ALONG THE VISIBLE CATHETER TRACK IN THE FRONT AND BACK, BUT SAW NO OBVIOUS SIGNS OF CATHETER DAMAGE OR KINKING. HE CUT OFF THE SUTURELESS CONNECTOR IN THE FRONT AND WAS THEN ABLE TO EASILY ASPIRATE CSF FROM THE EXISTING CATHETER. THEN, HE REPLACED IT WITH A NEW SUTURELESS CONNECTOR SEGMENT AND CONNECTED IT TO A NEW PUMP. AT THAT TIME, THE HCP WAS ABLE TO EASILY ASPIRATE CSF THROUGH THE CAP. IT WAS NOTED THAT IT WAS UNCLEAR IF THE RE-ESTABLISHMENT OF FLOW WAS DUE TO THE RELEASE OF TISSUE AROUND THE CATHETER OR DUE TO THE NEW SUTURELESS CONNECTOR. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT; THE PATIENT REPORTEDLY HAD GOOD EFFICACY AT A STABLE DOSE PRIOR TO THE SURGERY. AT THE TIME OF REPORT, THERE WAS NO PATIENT INJURY. THE DEVICE SYSTEM WAS BEING USED TO DELIVER GABLOFEN.

    Description of Event or Problem · 1

    PATIENT HISTORY INCLUDED TRAUMATIC BRAIN INJURY. AT THE TIME OF THE EVENT THE PATIENT ALSO TOOK MEDICATIONS INCLUDING CALCIUM, ROBINUL, VIGAMOX, SIMETHICONE, AND TOBRAMYCIN INHALER. THE REVISION TOOK PLACE ON (B)(6) 2014 AT WHICH TIME THE PUMP AND PROXIMAL PORTION OF THE CATHETER WERE EXPLANTED AND REPLACED. THE PUMP WAS REPLACED DUE TO END OF LIFE. THE CAUSE OF THE ASPIRATION DIFFICULTY WAS OCCLUSION OF THE PROXIMAL SEGMENT. AFTER THE SIDE PORT WAS UNABLE TO BE ASPIRATED, THE CATHETER WAS DISSECTED AND FREED TO DETERMINE THAT THERE WAS NO KINK; HOWEVER, THE SURGEON WAS STILL UNABLE TO ASPIRATE. THE PATIENT¿S PUMP WAS ABLE TO BE REFILLED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701195 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR