BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3140256 · Received May 31, 2013

    Report

    Report Number
    3004209178-2013-08474
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED A PUMP MEMORY ERROR (PME) OCCURRED. THE PME OCCURRED DURING AN UPDATE OF THE PUMP WITH NEW MEDICATION UPDATES. THE REPORTER TURNED THE PROGRAMMER OFF, BACK ON, RE-INTERROGATED THE PUMP, REPROGRAMMED AND RE-UPDATED THE PUMP, WHICH RESOLVED THE REPORTED ISSUE. THERE WAS NO THERAPY OR MEDICAL PROBLEM RELATED TO THE EVENT. THE PUMP WAS USED TO DELIVER BUPIVACAINE, GABLOFEN AND PRIALT. IT WAS NOTED THAT PRIALT WAS JUST ADDED TO THE PUMP THERAPY. DILAUDID WAS ALSO MENTIONED BY THE REPORTER, BUT THE INFORMATION WAS UNCLEAR AS TO IF THAT WAS A CURRENT THERAPY AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241290 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR