BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2063784 · Received April 15, 2011

    Report

    Report Number
    3007566237-2011-02839
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS NOT RECEIVING PAIN RELIEF AFTER MULTIPLE DOSE INCREASES. THE PHYSICIAN ATTEMPTED A CATHETER DYE STUDY; THE PHYSICIAN WAS UNABLE TO ASPIRATE ANY CSF BACK. THE PATIENT WAS SCHEDULED FOR A REVISION. WHEN THE PHYSICIAN OPENED THE SPINAL PORTION, HE NOTED THE CATHETER WAS NOT IN THE INTRATHECAL SPACE; IT WAS COILED UP IN THE FASCIA. THE ENTIRE CATHETER WAS REPLACED. THERE WAS NO NEGATIVE OUTCOME NOTED FOR THE PATIENT; THE PATIENT DID NOT HAVE ANY WITHDRAWAL SYMPTOMS; JUST WORSENING OF PAIN. FOLLOWING THE REVISION, THE PATIENT'S DOSE WAS REDUCED AND THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL 10,000 MCG/ML; THE DAILY DOSE WAS 8000 MCG/DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709, LOT# N095901011| IMPLANTED: