BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4402820 · Received January 9, 2015

    Report

    Report Number
    3004209178-2015-00417
    Event Type
    Injury
    Date Received
    January 9, 2015
    Date of Event
    December 20, 2014
    Report Date
    December 21, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED PUMP MOTOR GEAR TRAIN ANOMALY, CORROSION AND OR WEAR AND OR LUBRICATION, STALL DUE TO SHAFT BEARING. (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8709SC, LOT# N188532022, IMPLANTED: 2009-(B)(6), PRODUCT TYPE CATHETER. PRODUCT ID 8590-1, LOT# N151979, IMPLANTED: 2009-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE ACCESSORY. PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PUMP STALLED ON (B)(6) 2014 AT 08:39 AND RECOVERED (B)(6) 2014 AT 20:28. THERE WAS ONLY THE ONE MOTOR STALL. THE MOTOR STALL WAS NOT CAUSED BY THE PATIENT HAVING AN MRI OR OTHER MEDICAL PROCEDURE. THE PATIENT WAS AT HOME AT THE TIME OF THE STALL. THEY WERE CONCERNED ABOUT THE PUMP STALLING OVER THE HOLIDAYS. THE PATIENT¿S PAIN RETURNED AND THE PATIENT HAD WITHDRAWAL ASSOCIATED WITH THE EVENT. THE PUMP WAS REPLACED. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE-NO INJURY¿. THE DEVICE SYSTEM WAS DELIVERING BUPIVACAINE AND MORPHINE. THE OUTCOME WAS 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
    20740 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention