BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II PUMP

    MDR report key: 2932206 · Received January 18, 2013

    Report

    Report Number
    MW5028722
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE UNDERWENT REFILL PROCEDURE OF IT BACLOFEN PUMP. DURING REFILL, POCKET FILL OCCURRED. PT REQUIRED INTUBATION AND PCCU CARE BEFORE COMPLETE RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28625 SYNCHROMED II PUMP BACLOFEN PUMP LKK MEDTRONIC NEUROMODULATION 8637-20 NGP379803H

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| L