BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2073577 · Received April 26, 2011

    Report

    Report Number
    3004209178-2011-03097
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 11, 2011
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HOSPITALIZED AS A RESULT OF WITHDRAWAL SYMPTOMS. THE PUMP WAS ALARMING AND WAS FOUND TO BE IN "SAFE STATE" MODE WITH A MOTOR STALL NOTED UPON DEVICE INTERROGATION AS WELL AS A TUBE SET ERROR MESSAGE. THE ALARMS WERE RELATED TO A LOW BATTERY. THE PT WAS BEING "COVERED WITH ORAL MEDICINE" AND A PUMP REPLACEMENT WAS PLANNED. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE SUFENTANIL, MORPHINE AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT# B008365N22