BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3217169 · Received July 10, 2013

    Report

    Report Number
    3004209178-2013-11573
    Event Type
    Malfunction
    Date Received
    July 10, 2013
    Date of Event
    February 5, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8575, LOT# N081782, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013: PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, LOT# J10930R47, IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2013: PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PUMP INTERROGATION SHOWED THE ESTIMATED ERI (ELECTIVE REPLACEMENT INDICATOR) WAS 6 MONTHS. THE PUMP WAS REPLACED FOR BATTERY DEPLETION. THE CATHETER WAS ALSO REPLACED. THE PATIENT RECOVERED WITHOUT SEQUELA. THE SEVERITY OF THE EVENT WAS NOTED TO BE "MILD". THE PUMP WAS DELIVERING DILAUDID AND BUPIVACAINE. IT WAS LATER REPORTED THAT THE CATHETER WAS REPLACED BECAUSE THERE WAS NO CSF (CEREBROSPINAL FLUID) FLOW IN THE OR (OPERATING ROOM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317134 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR