BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3192713 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10957
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 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 Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. 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

    FINAL ANALYSIS OF THE PUMP FOUND SIGNIFICANT RESIDUE AND SHAFT WEAR ON THE UPPER SHAFT OF GEAR 2. ADDITIONALLY, THERE WAS CORROSION, MOISTURE, AND RESIDUE THROUGHOUT THE GEAR-TRAIN, INCLUDING SOME RESIDUE WAS FOUND ON THE JEWEL WHERE THE UPPER SHAFT OF GEAR 2 INSERTS INTO THE TOP BRIDGE ASSEMBLY. IT WAS NOTED THAT THE STALLS WERE DUE TO THE 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 PUMP HAD STALLED AND HAD YET TO RECOVER AT THE TIME OF REPORT. AT THAT TIME, THE PATIENT WAS IN THE EMERGENCY ROOM WITH WITHDRAWAL SYMPTOMS OF SWEATING, NAUSEA, AND VOMITING. UPON INTERROGATION OF THE DEVICE, THE EVENT LOGS SHOWED THAT THE STALL HAD OCCURRED THAT DAY AND THERE WERE NO OTHER MOTOR STALLS RECORDED. IT WAS STATED THAT THE PATIENT HAD A CT SCAN ABOUT A WEEK PRIOR TO REPORT, BUT THERE WAS NO KNOWN MRI DONE. IT WAS REPORTED THAT THE PUMP MIGHT BE REPLACED THAT NIGHT, BUT OTHERWISE THE PUMP MAY JUST BE SET TO MINIMUM RATE. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL AND BUPIVACAINE. THAT NEXT DAY, IT WAS REPORTED THAT THE PUMP HAD BEEN REPLACED ON THE PRIOR NIGHT. TWO DAYS LATER, IT WAS REPORTED THAT THE REASON FOR THE MOTOR STALL WAS UNKNOWN. IT WAS STATED THAT THE PATIENT WAS DOING FINE AFTER THE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292027 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention