BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3313377 · Received August 28, 2013

    Report

    Report Number
    3004209178-2013-15316
    Event Type
    Injury
    Date Received
    August 28, 2013
    Report Date
    August 5, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. ANALYSIS OF 8598A CATHETER (N305467006) FOUND A COMPRESSED AREA OF THE CATHETER BODY SEEN BETWEEN THE 26 AND 27 CENTIMETER (CM) MARKINGS. IT WAS 11CM AWAY FROM THE PIN CONNECTOR OF SEGMENT 2. ANALYSIS OF THE 8731SC CATHETER (N224387002) FOUND NO SIGNIFICANT ANOMALY. THE SUTURELESS CONNECTOR APPEARED TO HAVE BEEN DAMAGED AT EXPLANT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER; PRODUCT ID 87 31SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER; PRODUCT ID 8590-1, LOT# N223070, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: CATHETER: PRODUCT ID 8590-1, LOT# N223070, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A PRIOR CATHETER REVISION IN 2012 (REFER TO MANUFACTURER REPORT # 3004209178-2013-15308), THE PATIENT HAD ESCALATING DOSES OVER THE PAST YEAR WITHOUT EVER ACHIEVING THERAPEUTIC EFFECT. IT WAS NOTED THERE WERE MANY CONFOUNDING VARIABLES ALONG THE WAY INCLUDING HOSPITALIZATIONS FOR MEDICAL ISSUES THAT MAY HAVE BEEN CONTRIBUTING TO SPASTICITY. PATIENT SYMPTOMS INCLUDED LESS THAN FIFTY PERCENT THERAPY RELIEF AND STIFFNESS, WITH THE LOCATION BEING BOTH OF HER LEGS. THE PATIENT DECIDED TO DO A SIDE PORT ASPIRATION WHICH WAS COMPLETED ON THE DAY OF THIS REPORT. NO CEREBROSPINAL FLUID COULD BE ASPIRATED AND THE PATIENT WAS REFERRED TO A NEUROSURGEON FOR A ¿POSSIBLE¿ REVISION. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN. IT WAS LATER REPORTED THAT THE ONLY SYMPTOMS THE PATIENT EXPERIENCED WERE CONTINUED STIFFNESS AND POOR EFFICACY. THE PATIENT WAS STILL TO SEE A NEUROSURGEON TO FURTHER EVALUATE THE CATHETER BUT IT HAD YET TO OCCUR. IT WAS LATER REPORTED THAT THE PATIENT¿S MANAGING HEALTH CARE PROVIDER (HCP) ASSUMED THE CATHETER WAS ¿NOT WORKING¿. THE PATIENT WAS DOING ¿POORLY¿ AND WAS AWAITING A CATHETER REVISION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S DOSE HAD BEEN DECREASED FROM 1330 TO 506 MCG PER DAY SINCE AUGUST BY THE MANAGING HEALTH CARE PROVIDER (HCP) WITHOUT ANY NOTICEABLE DIFFERENT IN SPASTICITY. IT WAS NOTED THE PATIENT WAS ALSO TAKING 30MG OF ORAL BACLOFEN. THE PATIENT WAS SEEN FOR A PUMP REPLACEMENT AND CATHETER REVISION. INTRAOPERATIVELY, IT WAS NOTED THAT THE SPINAL SEGMENT OF THE CATHETER DID DRIP CEREBROSPINAL FLUID. NO OBVIOUS CATHETER MALFUNCTION WAS SEEN AT THE CONNECTION OR PROXIMAL SEGMENT BUT IT WAS TO BE RETURNED FOR ANALYSIS. THE SURGEON OPTED TO REMOVE THE ENTIRE EXISTING CATHETER AND REPLACE IT. THE PATIENT HAD REQUESTED A LARGER PUMP DUE TO A HISTORY OF FREQUENT REFILLS AND ¿WANING LIFE¿ OF THEIR CURRENT PUMP. THE PUMP WAS REPLACED WITH A 40ML PUMP. THE PATIENT WAS STARTED POST OPERATION ON A DOSE OF 100MCG PER DAY AND THE NEW DEVICE WAS FILLED WITH LIORESAL. THE PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT AND WAS TO GO TO INPATIENT REHAB FOR DOSE TITRATION WITH THE MANAGING HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424239 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R