BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2200816 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06138
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    January 1, 2010
    Report Date
    July 18, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANT, DUE TO AN UNEXPECTED TURN OF EVENTS, THE PT "SUDDENLY LOST THE USE OF HIS LEGS". THE BACLOFEN PUMP WAS NOTED AS HAVING FAILED THE WEEK OF (B)(6) 2010; AND THE PT HAD GONE INTO SEVERE WITHDRAWAL. AN ULTRASOUND GUIDED I.V. CONTRAST DIAGNOSTIC TEST CONFIRMED A KINK IN THE CATHETER, AND ALSO NOTED THAT THE CATHETER HAD RECOILED/RETRACTED BACK TO THE PUMP. THE CATHETER WAS REPLACED ON (B)(6) 2010. IT WAS NOTED THAT "IT WAS EVIDENT SOMETHING WAS NOT RIGHT A FEW HOURS AFTER SURGERY". BACLOFEN DOSE HAD TO BE INCREASED TO AS MUCH AS 600 MCG, WHEREAS BEFORE THE DEVICE FAILURE THE PT HAD OPTIMAL RESPONSE AT 259 MCG. AT 600 MCG, IT WAS NOTED THAT "WE HAD HARDLY ANY RESPONSE"; AND THE PT HAD PERSISTENT PAINFUL SPASMS / STIFFENING OF HIS LOWER EXTREMITIES WHICH MADE PHYSICAL THERAPY "VIRTUALLY IMPOSSIBLE". BRACES HAD BEEN PRESCRIBED, BUT DUE TO THE SPASTICITY IT WAS "IMPOSSIBLE" FOR THEM TO BE WORN. TWO DIAGNOSTIC TESTS WERE ORDERED AFTER A BOLUS WAS ADMINISTERED. THE PT HAD NO RESPONSE, AND THE BACLOFEN IN THE PUMP WAS REPLACED. AN ULTRASOUND FLUOROSCOPIC I.V. CONTRAST TEST REVEALED THERE WAS NO KINK IN THE CATHETER; HOWEVER, A "LOOP" WAS DETERMINED. THE TEST HAD MADE THE PT "VERY SICK" FOR THREE DAYS WITH HEADACHES, ABDOMINAL PAIN, AND SHIVERS. A SECOND DIAGNOSTIC TEST WAS DONE IN WHICH THE PUMP AND CATHETER WERE BYPASSED, AND A 75 MCG INJECTION/BOLUS DOSE OF BACLOFEN WAS ADMINISTERED INTO THE LUMBAR SITE VIA LUMBAR PUNCTURE. THE PT HAD AN IMMEDIATE AND SUCCESSFUL RESPONSE, THAT CONFIRMED A DEVICE MALFUNCTION, AND "THEREBY PUTTING TO REST THE THEORY" THAT THE PT MIGHT HAVE HAD A TOLERANCE TO BACLOFEN. IT WAS INDICATED THAT THE CATHETER HAD AGAIN RECOILED; AND A PHYSICIAN REPLACED THE ENTIRE DEVICE SYSTEM ON (B)(6) 2011. SINCE THEN THE PT HAD BEEN DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N250259005| CATHETER: MODEL 8731SC, LOT# N272628007