BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3050094 · Received April 10, 2013

    Report

    Report Number
    3007566237-2013-01185
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8781, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER; PRODUCT ID: 8781, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE IMPLANT OF THE PUMP THE THERAPY EFFECT COULD NOT BE CONFIRMED DESPITE AND INCREASED DOSE. A CONTRAST STUDY WAS PERFORMED TO EXAMINE THE CATHETER. THE PHYSICIAN ATTEMPTED TO DRAW CEREBRAL SPINAL FLUID (CSF) FROM THE CATHETER ACCESS PORT (CAP) HOWEVER; RESISTANCE WAS FELT AND THE CSF BUT COULD NOT BE ASPIRATED. THE PATIENT WAS SCHEDULED FOR A LAPAROTOMY ON (B)(6) 2013. UPON THIS IT WAS DISCOVERED THAT THERE WAS NO ABNORMALITY IN THE PUMP AND THE SPINAL CORD SIDE. IT WAS ALSO CONFIRMED THAT THERE WAS NO KINKING OR PINHOLES. THE PHYSICIAN CONSIDERED THAT THE CATHETER HAD BEEN POSITIONED OUTSIDE THE PITH CAVITY. IT WAS VERIFIED THAT THE CATHETER HAD NOT BEEN DISLODGED. RATHER, WITH A SENSE OF PERFORMING A PUNCTURE AGAIN, IT WAS CONSIDERED THAT THE CATHETER HAD BEEN POSITIONED OUTSIDE THE PITH CAVITY FROM THE BEGINNING AND WAS PROCEDURE RELATED. THE PUMP SIDE OF THE CATHETER WAS REPOSITIONED AND THE SPINAL SIDE WAS REPLACED. THERE WERE NO COMPLICATIONS AND THE REPORTED OUTCOME WAS NOT RECOVERED. THIS DEVICE SYSTEM DELIVERED GABALON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148868 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention