BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2143035 · Received June 23, 2011

    Report

    Report Number
    6000030-2011-04691
    Event Type
    Injury
    Date Received
    June 23, 2011
    Report Date
    May 27, 2011
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARM WAS HEARD; A LOW RESERVOIR ALARM WAS NOTED. THE PT'S PUMP WAS LAST REFILLED IN (B)(6) 2010. THE PT HAD NO MANAGING HCP AND INSURANCE ISSUES AT THE TIME OF THIS REPORT AND WAS LOOKING FOR AN HCP. THE PT EXPERIENCED RETURN OF SYMPTOMS. IT WAS NOTED THAT THE PT FELT "TINGLING IN HER TOES, BUT NOW SHE IS TINGLING/TWITCHING FROM HEAD TO TOE". IT WAS LATER STATED THAT THE PT DID NOT FEEL "ANYMORE TINGLY THEN SHE NORMALLY DOES"; "SYMPTOMS ARE THE SAME AS WHEN SHE IS RECEIVING THERAPY". THE PT HAD "A POOR MEMORY" AND APPEARED TO HAVE "LIMITED COGNITION". THE PT'S PHYSICAL CARE WAS PERFORMED BY HER HUSBAND. AN APPOINTMENT WAS SCHEDULED FOR (B)(6) 2011; THE PT HAD ORAL MEDICATIONS IN THE INTERIM. "TO GET HER THROUGH UNTIL THAT TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER: MODEL 8709, LOT# N10964R14| EXPLANTED:| IMPLANTED: