BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENDA

    MDR report key: 3893963 · Received June 25, 2014

    Report

    Report Number
    3007566237-2014-01767
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8637-40, SERIAL# (B)(4), IMPLANTED:(B)(6) 2014, PRODUCT TYPE PUMP. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER REVEALED NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THE CATHETER BODY WAS DEFORMED IN SHAPE AND OR ABRADED IN A WAY THAT DID NOT AFFECT INFUSION.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTEDLY HAD DIFFICULTY WITH THE CATHETER IMPLANT. IT WAS NOTED THAT HE "PUT IT IN, GOOD CSF (CEREBROSPINAL FLUID) FLOW IN NEEDLE, THREADED IT GREAT BUT THEN DIDN'T GET CSF FLOW FROM CATHETER." THE CATHETER WAS NOT IMPLANTED. IT WAS NOTED THAT "THEY HAD ISSUES" WITH THE SECOND CATHETER AS WELL BUT THE PHYSICIAN "GOT A SPOT WITH FREE-FLOWING CSF" SO THEY THINK THAT CATHETER IS OKAY. THE PUMP WAS INFUSING MORPHINE. IT WAS LATER REPORTED THAT THERE WAS NO EVIDENCE THAT THERE WAS A PROBLEM WITH THE CATHETER AFTER IT WAS REMOVED. IT WAS NOTED THAT THE TROUBLESHOOTING INCLUDED REPOSITIONING THE CATHETER MULTIPLE TIMES. THE PATIENT WAS REPORTEDLY "GOOD" FOLLOWING THE REPLACEMENT. IT WAS LATER REPORTED THAT THERE WAS GOOD (CSF) FLOW THROUGH THE NEEDLE BUT THEN NO FLOW THROUGH THE CATHETER. IT WAS NOTED THAT THE CATHETER WAS REPOSITIONED A FEW TIMES WITH THE SAME RESULT. THE CATHETER WAS NOT IMPLANTED AND RETURNED FOR ANALYSIS. THERE WAS NOTABLY NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELAE. THE REASON FOR CATHETER REMOVAL WAS QUESTIONABLY OCCLUSION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371640 ASCENDA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8780

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR