BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3231546 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11892
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT # J0039974R, IMPLANTED: (B)(6) 2000, 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 MOTOR GEAR TRAIN ANOMALY; CORROSION AND-OR WEAR AND-OR LUBRICATION. THE STALL WAS 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

    THE PUMP PRINTOUT ALSO REVEALED THAT THERE WAS MORE THAN ONE STALL WITH RECOVERY AND A TUBE SET OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALLED OCCURRED. THE PUMP WAS INTERROGATED AND LOGS WERE READ VERIFYING THE PUMP STALLED ON (B)(6) 2013. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH POTENTIAL DRUG WITHDRAWAL AND THE PUMP WAS TO BE REPLACED. THE PATIENT EXPERIENCED FLU-LIKE SYMPTOMS INCLUDING THE CHILLS AND FEVER AND HAD ITCHING. THIS DEVICE SYSTEM DELIVERED INFUMORPH. ON (B)(6) 2013 ((B)(4)): IT WAS LATER REPORTED THAT THE PUMP WAS REPLACED (B)(6) 2013) AND THERE WAS NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELA. ON (B)(6) 2013 ((B)(4)): NO NEW INFORMATION. ON (B)(6) 2013 (B)(4): NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331567 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention