BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4221706 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20870
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 9, 2014
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTHCARE PROVIDER (HCP) WAS UNABLE TO ASPIRATE FROM THE CATHETER ACCESS PORT (CAP) AND THE DOCTOR FELT THE PUMP HAD SOMETHING WRONG WITH IT AND THAT IT WAS SAFEST FOR THE PATIENT TO REPLACE IT. DIAGNOSTIC AND TROUBLESHOOTING PERFORMED INCLUDED A DYE STUDY, ROLLER STUDY, AND THE LOGS WERE CHECKED. IT WAS NOTED THE PATIENT¿S MULTIPLE SCLEROSIS (MS) SYMPTOMS AND SPASTICITY WERE NOT BEING HELPED BY THE PUMP. THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS ¿ALIVE-NO INJURY.¿ THE PUMP WAS REPLACED AND WAS TO BE TURNED IN FOR ANALYSIS. THE PUMP WAS BEING USED TO DELIVER GABLOFEN. PATIENT OUTCOME WAS NOT REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE ISSUE WAS CONSIDERED RESOLVED AFTER THE PUMP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702601 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention