BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3250152 · Received July 26, 2013

    Report

    Report Number
    3007566237-2013-02491
    Event Type
    Injury
    Date Received
    July 26, 2013
    Report Date
    July 1, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRATHECAL BACLOFEN (ITB) PHYSICIAN HAS OBSERVED A ¿DIFFERENCE IN DRUG FLOW¿ WAS SEEN WITH THE ASCENDA CATHETER. THE PHYSICIAN USED THE PLACE THE CATHETER AS HIGH AS C5-C6, BUT AFTER OBSERVING SEVERAL PATIENTS WHO HAD SIDE EFFECTS, HE ¿CAME UP WITH THIS THEORY¿. THE PHYSICIAN REVISED THE FIRST ASCENDA CATHETERS THAT HE PLACED AND USED T1-T2 AS THE NEW CATHETER LEVEL. IT WAS NOTED THAT THE PHYSICIAN HAD AROUND 7 PATIENTS WITH ASCENDA CATHETERS. IT WAS LATER REPORTED THAT THE PHYSICIAN DID NOT CHANGE DOSING OR CONCENTRATION. THE PREVIOUS CATHETER THAT THE PHYSICIAN USED WAS AN ¿OLDER¿ 2-PIECE CATHETER. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349918 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention