BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3942266 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-13200
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED INTO THE CLINIC ON (B)(6) 2014 WITH A SWOLLEN LUMBAR INCISION SITE AND INCREASED SPASTICITY. IT WAS NOTED THERE WAS SURGICAL INTERVENTION DONE, THE SITE WAS ASPIRATED AND THE NEUROSURGEON PERFORMED A BLOOD PATCH. THE PATIENT¿S SPASTICITY IMPROVED BUT STILL HAD FLUID COLLECTION AT SPINAL SITE AND ABDOMINAL SITE. IT WAS STATED THE PATIENT HAD SURGERY TO STITCH OVER THE CATHETER INCISION SITE. IT WAS NOTED THAT INTRA-OPERATIVELY WHEN THE SPINAL INCISION WAS MADE, ¿STRAW COLORED FLUID¿ RELEASED THAT HAD COLLECTED BENEATH THE SPINAL INCISION AND APPROXIMATELY 25CC STRAW COLORED FLUID WAS ASPIRATED FROM THE ABDOMINAL PUMP POCKET SITE WITH A NEEDLE AND SYRINGE. THE PUMP SYSTEM WAS DELIVERING GABLOFEN. THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ¿ALIVE-NO INJURY.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED ON (B)(6) 2014 INTRA-OPERATIVELY THE NEUROSURGEON HAD STATED ¿SIGNIFICANT PSEUDOMENINGOCELE¿ AT THE SPINAL ENTRY SITE FOR THE CATHETER CAUSING A CEREBRAL SPINAL FLUID (CSF) LEAK THAT TRACKED ALONG THE CATHETER TO THE PUMP POCKET WHICH WAS CAUSING SWELLING AT BOTH THE SPINAL AND THE PUMP POCKET SITE. NO DIAGNOSTICS WERE PERFORMED ON THE FLUID. NO ADDITIONAL INTERVENTIONS OR DIAGNOSTICS WERE PERFORMED. DURING THE MOST RECENT CLINIC VISIT ON (B)(6) 2014 THE INFUSION RATE WAS INCREASED FROM 240MCG/DAY TO 600MCG/DAY AND THE PATIENT WAS RESPONDING TO THE INTRATHECAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419285 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention