BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6989720 · Received October 31, 2017

    Report

    Report Number
    3004209178-2017-22808
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    October 27, 2017
    Report Date
    December 19, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    UDI-DI
    00613994779229
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP IDENTIFIED GEAR TRAIN ANOMALIES DUE TO CORROSION, WEAR AND/OR LUBRICATION, AND A STALL DUE TO SHAFT-BEARING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING GABLOFEN 2000MCG/ML AT 651MCG/DAY VIA AN IMPLANTABLE PUMP. THE INDICATIONS FOR USE WERE INTRACTABLE SPASTICITY AND CEREBRAL PALSY. IT WAS REPORTED THAT A MOTOR STALL OCCURRED ON (B)(6) 2017 @ 22:44 THAT DID NOT RECOVER. THE PATIENT DID NOT RECENTLY HAVE AN MRI. THE HEALTHCARE PROVIDER WANTED TO KNOW IT THERE WAS SOMETHING THAT COULD BE DONE TO RESTART THE PUMP AND IT WAS REVIEWED THAT THE PUMP COULD NOT BE FORCED TO RESTART. THE PATIENT WAS ADMITTED THROUGH THE ER (EMERGENCY ROOM) WITH RETURN OF SPASTICITY, INCREASED HEART RATE, DIAPHORESIS, HYPERTENSION AND SPASMS. THERE WERE NO KNOWN ENVIRONMENTAL, EXTERNAL OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE DIAGNOSTICS AND TROUBLESHOOTING PERFORMED WAS A MOTOR STALL NOTED IN THE PUMP LOGS. THE ACTIONS AND INTERVENTIONS TAKEN TO RESOLVE THE ISSUE WAS THE PUMP WAS REPLACED ON (B)(6) 2017. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE PATIENT STATUS WAS NOTED AS ALIVE, NO INJURY AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769338 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20 00613994779229

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| R