BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1823439 · Received August 25, 2010

    Report

    Report Number
    3004209178-2010-06443
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 28, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED WITHDRAWAL DUE TO PUMP FAILURE. A CRITICAL ALARM, TUBE SET, WAS HEARD DUE TO A MOTOR STALL. THE PUMP WAS IN A SAFE STATE MODE. THE DRUG BEING ADMINISTERED VIA THE PUMP WAS MORPHINE. THE PUMP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention CATHETER: MODEL 8711, LOT # N127925008| IMPLANTED:| EXPLANTED: