BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4091527 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17071
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 19, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 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 GEAR TRAIN ANOMALIES, INCLUDING CORROSION AND/OR WEAR AND/OR LUBRICATION AND A STALL DUE TO SHAFT- BEARING.

    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 EXPERIENCED AN ALTERED MENTAL STATUS, FEVER, PAIN, SWEATING, AND LESS THAN 50% THERAPY RELIEF. A CRITICAL ALARM OF AN UNKNOWN CAUSE OCCURRED. A MOTOR STALL DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) OCCURRED AND RECOVERED WITHIN 2 HOURS. A VOLUME DISCREPANCY OCCURRED, IN WHICH THE EXPECTED RESERVOIR VOLUME (ERV) WAS 3.2ML AND THE ACTUAL RESERVOIR VOLUME (ARV) WAS 15ML. THE CAUSE OF THE DISCREPANCY WAS NOTED TO BE UNKNOWN. HOWEVER, PER PUMP LOGS, CONTINUOUS MOTOR STALLS HAD BEEN OCCURRING SINCE (B)(6) 2014. THE STALLS OCCURRED MULTIPLE TIMES A DAY, ANYWHERE FROM 1 MINUTE TO AN HOUR IN DURATION. A PUMP REPLACEMENT WAS PLANNED FOR (B)(6) 2014. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571217 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention