BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2770544 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08832
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 11, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: UNKNOWN. PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ATTORNEY ALLEGES INFECTION DUE TO IMPAIRED HEALING RELATED TO PREVIOUS MULTIPLE PUMP REVISION/CATHETER REPLACEMENT PROCEDURES (SEE MANUFACTURER REPORT # 3004209178-2012-08830). THE PATIENT DEVELOPED AN INFECTION AT THE PUMP POCKET SITE, AND HAD THE PUMP SYSTEM EXPLANTED. IT WAS NOTED AT THE FOLLOW-UP VISIT WITH THE HEALTHCARE PROVIDER (HCP) ON (B)(6) 2011, WHEN THE INCISION WAS CHECKED, THERE WAS NO DRAINAGE PRESENT. AT THE FOLLOW-UP VISIT WITH THE HCP, THE PATIENT REPORTED HAVING BEEN TREATED WITH ANTIBIOTICS AT THE END OF (B)(6) 2011 FOR A "STITCH ABSCESS". AT THE FOLLOW UP ON (B)(6) 2011, THE HCP ORDERED A WBC AND SED. RATE TESTS WHICH RESULTED WITHIN NORMAL LIMITS. THERE WAS NO FEVER OR CHILLS PRESENT AT THAT TIME AND THE INCISION WAS CLEAN, DRY AND INTACT, WITH ERYTHEMATOUS AND TENDERNESS NOTED. THE PATIENT WAS INSTRUCTED TO FOLLOW UP IN 2 WEEKS FOLLOWING THE (B)(6) 2011 APPOINTMENT, BUT "THAT DID NOT OCCUR" PER THE HCP. IT WAS LATER ON (B)(6) 2011 THE PATIENT REPORTED YELLOW AND BLOODY DRAINAGE SINCE (B)(6) 2011. A SUPERFICIAL INFECTION WAS NOTED AT THAT TIME. THE PATIENT HAD FEVER AND CHILLS, BUT ALSO INDICATED THEY HAD THE FLU RECENTLY. THE WOUND "HAD BEEN POURING ALL WEEKEND"; HOWEVER NO DRAINAGE WAS NOTED BY THE HCP AT THAT TIME. LATER ON (B)(6) 2011, THE PATIENT REPORTED TO THE EMERGENCY ROOM WITH A RETURN OF SYMPTOMS, STATING "THE PUMP HAD NOT WORKED FOR THREE MONTHS". THE PATIENT WAS LATER ADMITTED TO THE HOSPITAL ON (B)(6) 2012 FOR EVALUATION, DUE TO THE BACK PAIN. THE PATIENT AND FAMILY INDICATED THAT PUMP TO BE "INACTIVE" AND "LEAKING"; HOWEVER THE HCP WAS UNABLE TO VISUALIZE ANY LEAK UPON EXAMINATION. THE REPORTER STATED THAT THE PATIENT OFTEN RETURNED TO THE HCP WITH COMPLAINTS OF RETURNED PAIN AND/OR PAIN LEVELS APPROACHING MAXIMUM; THE PATIENT REPORTEDLY "KNOWS WHEN THE PUMP IS WORKING AND WHEN IT IS NOT WORKING. THE HCP NOTED ON (B)(6) 2012 POSSIBLE WOUND INFECTION AND LEAKAGE OF FLUID, AND ADMITTED PATIENT TO THE HOSPITAL AT THAT TIME. ON (B)(6) 2012, THE PATIENT HAD A DIAGNOSIS OF INFECTED INTRATHECAL PAIN PUMP. ULTRASOUND REVEALED A SEROMA CONSISTENT WITH AN ABSCESS. CULTURES WERE TAKEN FROM THE INCISION AT THE PAIN PUMP. THE PUMP WAS THEN REMOVED ON (B)(6) 2012 AT WHICH TIME THE PATIENT HAD DRAINAGE FROM THE INCISION, AND INDICATED IT HAD BEEN "DRAINING FOR A NUMBER OF WEEKS". THE THICKER PORTION OF THE CATHETER WHICH WENT FROM THE PUMP DISTALLY, WAS REMOVED IN ONE PIECE WITH THE PUMP. IT WAS ALSO REPORTED AT THAT TIME THAT THE PATIENT UNDERWENT AN ULTRASOUND DOPPLER OF LOWER EXTREMITY, WHICH WAS POSITIVE FOR DEEP VEIN THROMBOSIS. IT WAS EARLIER REPORTED THAT THE PATIENT WAS EXPERIENCING LOWER EXTREMITY PAIN DURING THIS EVENT. ON (B)(6) 2012, THE PUMP WAS RE-IMPLANTED. AT THE TIME OF IMPLANT, THE HCP WAS UNABLE TO ACCESS THE OLD CATHETER, THEREFORE IT WAS REMOVED. IT WAS UNCLEAR IF THE PREVIOUS CATHETER HAD REMAINED IMPLANTED AT THE TIME THE PUMP WAS REMOVED ON (B)(6) 2012. THE NEW PUMP WAS PLACED AND FILLED WITH MORPHINE SULFATE. THE ATTORNEY ALLEGES THAT "THE ABSCESS AND THE INFECTION WERE PROXIMATELY RELATED TO BEING CUT ON SO FREQUENTLY WITH THE INABILITY OF HER BODY TO TIMELY HEAL." A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R