BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3973574 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13834
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 9, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE MANUFACTURE REPRESENTATIVE RECEIVED A TEXT QUESTIONING WHAT ¿8476¿ WAS. IT WAS REVIEWED THIS WAS A MOTOR STALL CODE ON THE PTM. ADDITIONAL INFORMATION LATER REPORTED TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING. THE ALARM WAS DUE TO A MOTOR STALL. THE PATIENT NOTICED AN ERROR CODE ON THEIR PTM INDICATING THE PUMP MOTOR HAD STALLED. THE REPORTER READ THE PUMP THE DAY OF THE REPORT AND IT SHOWED A MOTOR STALL OCCURRED LAST NIGHT ((B)(6) 2014) AT 21:48 AND HAD NOT RECOVERED YET. THE PATIENT WAS HAVING WITHDRAWAL-TYPE SYMPTOMS INCLUDING VOMITING. PER THE REPORTER THE HCP WAS TRYING TO SCHEDULE A PUMP REPLACEMENT FOR LATER THE DAY OF THE REPORT. THE PUMP WAS USED TO DELIVER CLONIDINE, BUPIVACAINE, AND MORPHINE. ADDITIONAL INFORMATION LATER REPORTED THE PATIENT¿S PUMP WAS SCHEDULED TO BE REPLACED (B)(6) 2014. ADDITIONAL INFORMATION LATER REPORTED THE PUMP WAS STALLED GREATER THAN 24 HOURS AND THERE WAS A TUBE SET MESSAGE AFTER THE STALL. THE MOTOR STALL OCCURRED (B)(6) 2014 AT 21:22. THE "STOPPED PUMP PERIOD MAY EXCEED TUBE SET" MESSAGE OCCURRED ON (B)(6) 2014 AT 21:22. THERE WAS NOT MORE THAN ONE MOTOR STALL NOTED IN THE EVENT LOGS. THE CAUSE OF THE MOTOR STALL WAS UNKNOWN. THE PATIENT REPORTED NOT HAVING AN MRI, OR ANY POSSIBLE INTERACTION OF MAGNET ELECTROMAGNETIC INTERFERENCE. THE PATIENT WAS ADMITTED TO HOSPITAL WHEN IT WAS LEARNED THE MOTOR STALL HAD NOT RECOVERED TO CONTROL WITHDRAWAL SYMPTOMS. THE PROCEDURE WENT AS EXPECTED. THE CATHETER WAS INTACT BECAUSE HCP CONFIRMED GOOD CSF FLOW IN THE O.R. THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451463 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R