BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3140601 · Received May 31, 2013

    Report

    Report Number
    3004209178-2013-08489
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 7, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1579-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    FINAL ANALYSIS OF THE PUMP FOUND CORROSION ACROSS THE INSULATION OF THE M1 FEED-THRU. THERE WAS ALSO SIGNIFICANT RESISTANCE WHEN MANUALLY TRYING TO TURN GEAR THREE WHEN ISOLATED FROM THE REST OF THE GEAR-TRAIN. THERE WAS SIGNIFICANT RESIDUE ON GEAR THREE¿S O-RING LOCATED ON THE TOP BRIDGE.

    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 PUMP WAS ALARMING DUE TO A MOTOR STALL. AS THE STALL HAD NOT RECOVERED, THE PUMP WAS EXPLANTED AND REPLACED. THE REPORTER DID NOT KNOW IF THE PATIENT HAD PRESENTED WITH UNDERDOSE SYMPTOMS. THE DEVICE HAD BEEN DELIVERING COMPOUNDED BACLOFEN. SIX DAYS LATER, IT WAS REPORTED THAT MULTIPLE MOTOR STALLS AND RECOVERIES HAD OCCURRED OVER A TWO DAY PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241010 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention