BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4387943 · Received January 6, 2015

    Report

    Report Number
    3004209178-2015-00203
    Event Type
    Injury
    Date Received
    January 6, 2015
    Report Date
    December 16, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-1, LOT# N201184, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED TO THE ER (EMERGENCY ROOM) WITH SEIZURES AND THE PATIENT¿S CAREGIVER TOLD THE HEALTHCARE PROVIDER THE PUMP NEEDED TO BE REFILLED. OPTIONS, INCLUDED HAVING THE PUMP INTERROGATED BY A COMPANY REPRESENTATIVE AND CALLING THE PATIENT¿S PUMP MANAGING PHYSICIAN TO HAVE THE PUMP REFILLED WERE BEING CONSIDERED. THE PUMP WAS DELIVERING BACLOFEN. THE CAUSE OF THE EVENT, INTERVENTIONS/TREATMENT, TROUBLESHOOTING/DIAGNOSTICS, AND FINAL PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9168 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Other