BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5411011 · Received February 4, 2016

    Report

    Report Number
    3004209178-2016-01558
    Event Type
    Injury
    Date Received
    February 4, 2016
    Date of Event
    January 10, 2016
    Report Date
    January 11, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS REPORTED BY A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING GABLOFEN (2000 MCG/ML AT 276 MCG/DAY, LOT# 2163-113). THE INDICATION FOR USE WAS CEREBRAL PALSY. IT WAS REPORTED THAT THE PATIENT WAS SEEN BY AN HCP ON (B)(6) 2016 AND THE PUMP WAS FOUND TO BE ALARMING DUE TO A MOTOR STALL. IT WAS NOTED THAT THE ELECTIVE REPLACEMENT INDICATOR WAS AT NINE MONTHS, THE ALARMS WERE RESET AND THE PUMP STARTED TO ALARM AGAIN. THE PATIENT WAS BEING COVERED WITH ORAL BACLOFEN AND THE PUMP NEEDED TO BE REPLACED. ADDITIONAL INFORMATION WAS REPORTED BY THE REP ON 2016-01-12. A CONSUMER REPORTED THAT THE PATIENT WAS EXPERIENCING SHAKES, ELEVATED HEAR RATE, AND HIGH BLOOD PRESSURE. IT WAS NOTED THAT NO TROUBLESHOOTING HAD BEEN DONE, THE LOGS WERE READ AND IT WAS DETERMINED THAT THE PUMP MOTOR HAD STALLED ON (B)(6) 2016. ADDITIONAL INFORMATION WAS REPORTED BY THE REP ON 2016-01-17. THE PUMP WAS REPLACED ON (B)(6) 2016. DURING THE REVISION THE CATHETER WAS ASPIRATED WITH POSITIVE RETURN OF CEREBROSPINAL FLUID (CSF) THROUGH THE EXISTING CATHETER AND THROUGH THE CATHETER ACCESS PORT OF THE NEW PUMP ONCE IT WAS ATTACHED. THE NEW PUMP WAS FILLED 20CC OF 2000 MCG/ML OF GABLOFEN, LOT #2138-106. THE NEW PUMP WAS STARTED POST-OP BY THE HCP, THE INTERNAL PUMP TUBING AND CATHETER WERE PRIMED AND NEW PUMP WAS STARTED AT 100 MCG/DAY. AT EXPLANT, THE PUMP LOGS WERE READ AND THEY SHOWED THAT A MOTOR STALL OCCURRED ON (B)(6) 2016 AT 5:44. A TUBE SET MESSAGE OCCURRED ON (B)(6) 2016 AND THE MOTOR STALL RECOVERED IN (B)(6) 2016 AT 6:53. THE MOTOR STALLED AGAIN ON (B)(6) 2016 AT 6:59 AND RECOVERED AT 6:04 ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67294 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 YR Required Intervention