BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4093276 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17084
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 21, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8703W, LOT# L34869, IMPLANTED: (B)(6) 1995, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED PUMP/MOTOR/GEAR TRAIN ANOMALY/CORROSION AND-OR WEAR AND-OR LUBRICATION AND STALL DUE TO SHAFT-BEARING.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A CONFIRMED MOTOR STALL NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. THE PHYSICIAN TRIED TO RESTART THE PUMP AND SENT THE PATIENT HOME. THE PUMP THEN STALLED AGAIN. THE DATES OF THE STALL WERE NOT KNOWN AT THE TIME OF THE REPORT. IT WAS REPORTED THE PATIENT EXPERIENCED WITHDRAWAL. THE SYSTEM WAS EXPLANTED ON (B)(6) 2014 DUE TO MULTIPLE MOTOR STALLS AND THE PATIENT RECOVERED WITHOUT SEQUELAE. THERE WAS NO PATIENT INJURY. NO ROTOR STUDY OR DYE STUDIES WERE PERFORMED. THE SYSTEM WAS BEING USED TO DELIVER COMPOUNDED BACLOFEN AND FENTANYL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE MOTOR STALL WAS UNKNOWN. IT WAS ALSO NOTED THAT THE PUMP KEPT BEEPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571126 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention