BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3240686 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12086
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    July 2, 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
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731SC LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2013 (B)(6), 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

    ADDITIONAL INFORMATION/EVALUATION SUMMARY: ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND. ANALYSIS OF THE CATHETER REVEALED A HOLE IN THE CATHETER BODY CAUSE BY A DEEP ABRASION.

    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 WASN¿T GETTING PAIN RELIEF EVEN AFTER DOSE ADJUSTMENTS. INTERROGATION OF THE PUMP AND THE PUMP LOGS DID NOT REVEAL ANYTHING MALFUNCTIONING IN THE PUMP. THE PUMP AND CATHETER WERE REPLACED. THERE WERE NO VISIBLE SIGNS OF DAMAGE TO THE CATHETER; THE SURGEON CUT IT TO REMOVE IT. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE ¿ NO INJURY¿. THE PUMP WAS DELIVERING INFUMORPH. IT WAS LATER REPORTED THAT THE CATHETER HAD A BREAK/TEAR/HOLE THAT COULD NOT BE SEEN PRIOR TO THE SURGEON CUTTING IT AND REMOVING IT FROM THE PATIENT. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341796 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention