BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2981526 · Received February 27, 2013

    Report

    Report Number
    3007566237-2013-00620
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    January 31, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAME "CATHETER TRACK" WAS USED WHEN REPLACING THE PATIENT'S CATHETER IN (B)(6) 2012. FOLLOWING REPLACEMENT, THE PATIENT EXPERIENCED A CEREBRAL SPINAL FLUID (CSF) LEAK. THE PATIENT HAD A SURGICAL PROCEDURE ON (B)(6) 2013 TO SEE IF THE CSF LEAK HAD RESOLVED WHICH IT HAD. THERE WERE NO FURTHER ISSUES. THE PUMP WAS BEING USED TO DELIVER GABLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CEREBROSPINAL FLUID (CSF) LEAK WAS AT THE SPINE. THE PATIENT DID NOT H AVE ANYTHING DEVICE REPLACED THAT DAY. THE PROCEDURE HAD BEEN TO CORRECT THE CSF LEAK, BUT IT HAD RESOLVED. NO OTHER TROUBLESHOOTING HAD OCCURRED. THE REPORTER BELIEVED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83695 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention