BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3190921 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10915
    Event Type
    Injury
    Date Received
    June 26, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE OUTCOME WAS RESOLVED WITH SEQUELAE, RESOLVED DATE OF (B)(6) 2013, NOTING SEQUEL ¿EVENTUALLY PATIENT GETS INFECTED PUMP AND CATHETER AND HAS IT REMOVED (B)(6) 2013.¿ INTERVENTION INCLUDED ¿ATTEMPT TO SUTURE LEAK SITE (B)(6) 2013. SURGICAL REPOSITIONING CATHETER PULLED BACK 1 ½ CM (B)(6) 2013. A BLOOD PATCH WAS DONE (B)(6) 2013. THERAPY WAS SUSPENDED (B)(6) 2013. CATHETER SPLICE, REPLACED SPINAL PORTION OF CATHETER (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXAMINATION AND PALPATION REVEALED A SMALL CEREBROSPINAL FLUID LEAK AT THE LUMBAR SPINE INCISION SITE ON (B)(6). THREE DAYS LATER, AN ATTEMPT WAS MADE TO SUTURE THE LEAK SITE. IT WAS FOUND THAT THE EVENT WAS CAUSED BY A PIECE OF THE OLD CATHETER THAT BROKE OFF DURING THE REPLACEMENT PROCEDURE. ON (B)(6), THE SURGEON PERFORMED A ¿L3-4 LAMINOTOMY¿ WITH THE USE OF AN OPERATING MICROSCOPE TO REMOVE THE OLD CATHETER AND REPAIR THE LEAK. IT WAS REPORTED THAT, TEN DAYS LATER, THE EVENT HAD RESOLVED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS BEING USED TO DELIVER LIORESAL.

    Description of Event or Problem · 1

    REFER TO MANUFACTURER REPORT #3004209178-2013-20464 FOR DETAILS OF THE PREVIOUSLY REPORTED INFECTION AND SUBSEQUENT EXPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT RESULTED IN IN-PATIENT OR PROLONGED HOSPITALIZATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT EXAMINATION AND PALPITATION ON (B)(6) HAD REVEALED THERE WAS CLEAR DRAINAGE AT THE SITE AGAIN. ON (B)(6), A SURGICAL REPOSITIONING WAS DONE TO PULL BACK THE CATHETER 1.5CM. IT WAS ALSO NOTED THAT A BLOOD PATCH HAD BEEN SURGICALLY APPLIED ON (B)(6). IN ADDITION, ON (B)(6), THE INFUSION THERAPY HAD BEEN SUSPENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290075 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR Hospitalization| R