BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 4582888 · Received March 9, 2015

    Report

    Report Number
    3007566237-2015-00555
    Event Type
    Malfunction
    Date Received
    March 9, 2015
    Report Date
    February 17, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A MEDTRONIC PAIN PUMP MOVE AND THEY NEEDED A HEALTH CARE PROVIDER (HCP). THE PATIENT HAD A PAIN PUMP IMPLANTED. THE PUMP HAD FLIPPED. THEY NEEDED A PAIN DOCTOR IN THE COLUMBUS, OHIO AREA ¿ASAP¿. THE DRUG INFORMATION WAS NOT KNOWN AT THE TIME OF THE REPORT. NO INTERVENTIONS WERE REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161348 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1