BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3200011 · Received July 1, 2013

    Report

    Report Number
    3007566237-2013-00992
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    January 15, 2005
    Report Date
    February 17, 2005
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PRODUCT ID: NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A TELEMETRY FAILURE WHILE INTERROGATING THE PUMP. CONTACT WAS LOST WITH THE TELEMETRY HEAD AND A PUMP MEMORY ERROR OCCURRED. THE DIFFICULTY OCCURRED WHILE CHANGING A NEWLY IMPLANTED PUMP FROM SHELF STATE TO RUN STATE. THERE WAS AN INVALID TELEMETRY MESSAGE. THE PUMP WAS INTERROGATED AGAIN AND THIS IS WHEN THE PUMP MEMORY ERROR MESSAGE OCCURRED ALONG WITH A PUMP STOPPED MESSAGE. THE LOGS WERE READ AND THEY SHOWED A MOTOR STALL OCCURRED (B)(6) 2005, TUBE SET OCCURRED (B)(6) 2005, AND A MOTOR STALL RECOVERY OCCURRED (B)(6) 2005. THE PUMP WAS THEN UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297925 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1