BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3882422 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-11787
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    May 28, 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
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED GEAR TRAIN ANOMALIES, INCLUDING CORROSION AND/OR WEAR AND/OR LUBRICATION AND A STALL DUE TO SHAFT- BEARING.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD AN ALARM ¿OVER THE WEEKEND¿ AND WENT TO THE HEALTHCARE PROVIDER¿S (HCP) OFFICE ON THE REPORT DATE. TELEMETRY CONFIRMED THAT A MOTOR STALL OCCURRED ON 2014 (B)(6), WITH A TUBE SET MESSAGE TWO DAYS LATER. THE PATIENT WAS ¿NOT IN GOOD SHAPE¿ WHEN HE WENT INTO THE HCP¿S OFFICE. THE HCP PROGRAMMED A 1MG BOLUS FOR THE PATIENT AND THE PATIENT FELT GREAT WITHIN 10 MINUTES AND ALL VITAL SIGNS WERE STABLE. THE HCP SENT THE PATIENT HOME AND CALLED HIM AND HE WAS DOING WELL. 10 MINUTES PRIOR TO THIS REPORT, THE PATIENT CALLED THE HCP TO REPORT THAT HE WAS HEARING THE ALARM AGAIN. THE HCP DID NOT RUN THE LOGS AFTER THE 1MG BOLUS AND NEVER SAW A MOTOR STALL RECOVERY. THE HCP WAS TO BRING THE PATIENT BACK INTO THE OFFICE AND REREAD THE LOGS. NO MRI WAS DONE AND THE PATIENT WAS AT HOME WHEN THE EVENT OCCURRED. IT WAS NOTED THAT THE PATIENT HAD A BACK SURGERY IN (B)(6), WHICH WAS NOT PUMP-RELATED. FOLLOW-UP INFORMATION INDICATED THAT THE PATIENT WENT BACK TO THE HCP¿S OFFICE FOR A SECOND TIME TO CHECK THE PUMP STATUS. THE PUMP LOGS SHOWED A CONTINUED MOTOR STALL. THERE WAS NO MOTOR STALL RECOVERY, DESPITE THE FACT THAT THE PATIENT FELT A LITTLE BETTER POST-BOLUS AT THE INITIAL VISIT. AT THE TIME OF THIS REPORT, THE PATIENT WAS NOT FEELING WELL AGAIN. THE PUMP WAS PROGRAMMED TO MINIMUM RATE MODE AND THE PATIENT WAS GIVEN ORAL MEDICATION. A PUMP REPLACEMENT WAS SCHEDULED FOR THE NEXT 1-2 WEEKS. THE DEVICE SYSTEM WAS USED TO DELIVER BUPIVACAINE AND MORPHINE. NO NEW REPORTABLE INFORMATION. IT WAS LATER REPORTED THAT THE PATIENT HEARD A CRITICAL ALARM ON 2014 (B)(6). THE MOTOR STALL OCCURRED ON THIS DATE ON 20:21 FOR AN UNKNOWN REASON. THE PATIENT WENT THROUGH WITHDRAWALS. THE PUMP WAS REPLACED ON 2014 (B)(6). THE PATIENT RECOVERED WITHOUT SEQUELAE. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED ACUTELY WORSENING PAIN AND OPIATE WITHDRAWAL AND INSOMNIA FOR SEVERAL DAYS. AT THE PUMP REPLACEMENT, THE CATHETER WAS DETERMINED TO BE PATENT AND FUNCTIONING. PER PUMP LOGS, A MOTOR STALL OCCURRED ON 2014 (B)(6) AT 09:46 WITH A RECOVERY AT 10:47 ON THE SAME DATE. A MOTOR STALL OCCURRED ON 2014 (B)(6) AT 20:29 WITH A TUBE SET MESSAGE TWO DAYS LATER AT 20:29. NO MOTOR STALL RECOVERY WAS LOGGED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT AN EMERGENCY PUMP REPLACEMENT WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357531 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention