BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4260332 · Received November 18, 2014

    Report

    Report Number
    3004209178-2014-21834
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 28, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, 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 HIGH BATTERY RESISTANCE. THERE WAS SLIGHT WEAR PRESENT ON THE INLET AND OUTLET PORTION OF THE PUMP TUBE. GEAR THREE¿S O-RING WAS ALSO DAMAGED.

    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 SOME SYMPTOMS OF WITHDRAWAL. ON THE DATE OF THIS REPORT, PUMP TELEMETRY WAS DONE AND CONFIRMED THAT ¿RESET OCCURRED¿, ¿RESET OCCURRED-LOW BATTERY¿ AND ¿PUMP IN SAFE STATE¿ ALARMS OCCURRED ON (B)(6) 2014 AT 16:19. AT THIS TIME, THE EXPECTED RESERVOIR VOLUME (ERV) WAS 17.2ML AND 18ML WAS OBTAINED AND WASTED. THE PUMP WAS REPLACED ON THE SAME DATE. FOLLOWING EXPLANT, THE MANUFACTURER REPRESENTATIVE WAS UNABLE TO SILENCE THE PUMP ALARM. AS OF (B)(6) 2014, THE PATIENT WAS DOING WELL. THE DEVICE SYSTEM WAS USED TO DELIVER INFUMORPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744701 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Required Intervention