BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3082166 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-04699
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    June 12, 2012
    Report Date
    June 12, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE PUMP REFILL ON THE DATE OF THIS REPORT. A VOLUME DISCREPANCY WAS NOTED. THE ACTUAL RESIDUAL VOLUME WAS 9 ML AND THE EXPECTED RESIDUAL VOLUME WAS 1.9 ML. THE PATIENT OUTCOME WAS UNKNOWN. THE PUMP WAS BEING USED TO DELIVER DILAUDID AND BUPIVACAINE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THERE WERE NO VOLUME DISCREPANCIES IN THE HISTORY AND PATIENT DOES HAVE LEFT OVER DRUG IF PATIENT DOES NOT ACCESS ALL HIS BOLUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184609 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR