BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201559 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04750
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    February 7, 2012
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8840 SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROGRAMMING MISTAKE WAS MADE. IF THE PUMP HAD NOT BEEN RE-PROGRAMMED AND THE PATIENT HAD GONE HOME, THE PATIENT ¿WOULD NOT HAVE BEEN AWAKE BY THE NEXT MORNING.¿ THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL, CLONIDINE, AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303337 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1