BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4213875 · Received October 30, 2014

    Report

    Report Number
    3004209178-2014-20657
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CONFIRMED MOTOR STALL WITH NO MOTOR STALL RECOVERY RECORDED IN THE EVENT LOGS. PUMP LOGS SHOW A MOTOR STALL OCCURRED ON (B)(6) 2014 AND A STOP PUMP PERIOD MAY EXCEED TUBE SET MESSAGE WITH NO MOTOR STALL RECOVERY NOTED. THE PATIENT HEARD BEEPS AND WENT THROUGH WITHDRAWAL THE PRIOR WEEK WITH THE TIMING BEING CONSISTENT WITH WHEN THE MOTOR STALL OCCURRED. THE PATIENT ALSO EXPERIENCED SEVERE PAIN. THE CAUSE OF THE MOTOR STALL WAS UNKNOWN. NO ROTOR OR DYE STUDY WAS PERFORMED. THE PATIENT¿S PUMP WAS EXPLANTED AND REPLACED ON (B)(6) 2014. THE PATIENT HAD NO INJURY AND RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO INFUSE FENTANYL AND MORPHINE. NO ADDITIONAL INFORMATION WAS REPORTED REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697523 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