BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 4242799 · Received November 11, 2014

    Report

    Report Number
    3007566237-2014-03290
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 29, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER ANCHOR FAILED TO DEPLOY. IT BUNCHED UP ON THE DEPLOY DEVICE EVEN AFTER SEVERAL ATTEMPTS TO ROTATE ON THE METAL ROD. THE CATHETER WAS IMPLANTED WITHOUT A CATHETER. PATENCY OF THE CATHETER WAS CONFIRMED. THE PRODUCT ISSUE WAS RESOLVED. THERE WAS EITHER A BATCH ISSUE OR A DESIGN ISSUE AS THE PROBLEM HAD BEEN SEEN BEFORE. THE ANCHOR WAS STUCK TO TIGHT OR CHEMICALLY TO THE TIP OF THE METAL ROD AND WOULD NOT SLIDE ONTO THE CATHETER. THERE WERE NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ¿ALIVE ¿ NO INJURY.¿ IT WAS INITIALLY REPORTED THAT THE DEVICE WAS IMPLANTED (B)(6) 2014, BUT FOLLOW UP INFORMATION RECEIVED INDICATED THE EVENT WAS REPORTED ON (B)(6) 2014. THE SYSTEM WAS BEING USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725576 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR