BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3013316 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-03993
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 20, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL 8709, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), ACCESSORY: MODEL 8590-1, LOT# N223070, IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6). (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

    FINAL DEVICE ANALYSIS OF THE INFUSION PUMP REVEALED THE FOLLOWING: THERE WERE NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROPHYLACTIC REPLACEMENT CATHETER AND PUMP REVISION OCCURRED. SURGERY WAS TO "TACK DOWN" THE PUMP, DURING SURGERY THE PHYSICIAN DECIDED TO REPLACE THE PUMP "DESPITE" IT "STILL" HAVING 46 MONTHS ON IT. THE PUMP HAD FLIPPED MULTIPLE TIMES AND THERE WAS "SEVERE KINKING" TO THE PROXIMAL PIECE OF THE CATHETER, "YET" THERE WAS "STILL EXCELLENT CEREBROSPINAL FLUID FLOW. 7.6CM OF THE KINKED CATHETER WERE CUT OFF, AND A NEW CATHETER CONNECTOR WAS PLACED" BECAUSE IT HAD A COUPLE OF BENDS IN IT, THE SURGEON "THOUGHT A NEW CONNECTOR WOULD BE A GOOD IDEA." THERE WAS "NO REPORT OF ANY ISSUES" WITH THE PUMP BEFORE IT WAS PROPHYLACTICALLY REMOVED. THE PATIENT WAS DISCHARGED TO HOME THE SAME DAY AS THE REPLACEMENT. PATIENT STATUS WAS NOT KNOWN AS OF THE DATE OF THIS REPORT. THE DEVICE SYSTEM WAS USED TO INFUSE MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115787 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention