BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3951489 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13397
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD NO SYMPTOMS. THE HEALTHCARE PROFESSIONAL (HCP) MADE THE DECISION TO TURN THE PUMP OFF BECAUSE THEY DON¿T LIKE TO MANAGE PATIENTS WITH THESE TYPES OF DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD EXTENSIVE BACK SURGERY EITHER EARLIER IN THE WEEK OR LAST WEEK. DURING THE PROCEDURE, THE CATHETER TIP BECAME DISLODGED FROM THE INTRATHECAL SPACE. THE HEALTHCARE PROFESSIONAL (HCP) DECIDED TO STOP THE PUMP AND ELECTED TO MANAGE THE PATIENT WITH ORAL MEDICATION. THE MANUFACTURER REPRESENTATIVE REPROGRAMMED THE PUMP TO STOPPED. THE PATIENT WAS NOT AWAKE WHEN THE REP SAW HIM TO TURN THE PUMP OFF. THE PUMP WAS USED TO DELIVER MORPHINE, BUPIVACAINE AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429047 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR