BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2935675 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01129
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 14, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS NOT EXPERIENCING PAIN RELIEF. A CATHETER DYE STUDY WAS DONE (B)(6) 2013. THE CATHETER TIP WAS EPIDURAL, NOT DISLODGED FROM THE INTRATHECAL. THE DYE POOLED AND DID NOT DISPERSE. THE DRUG VOLUME OF 0.203 WAS PUSHED IN DURING THE DYE STUDY. IT WAS INDICATED THAT 2.03MG WAS DELIVERED FIRST PRIOR TO THE DYE; THE ACTUAL DOSE WAS NOT 2.3MG AS THE CATHETER WAS EPIDURAL. THE PATIENT WAS FINE. THE PLAN WAS TO REVISE THE CATHETER TO BE INTRATHECAL. THE PATIENT WAS ON 1.9 A DAY. THE DOCTOR REDUCED THIS BY 20% DUE TO URINE RETENTION. THE PUMP WAS DELIVERING INFUMORPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40336 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention