BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 3812669 · Received May 15, 2014

    Report

    Report Number
    3007566237-2014-01329
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CHANGE WITH HIS INSURANCE WITHOUT PROPERLY NOTIFYING HIS MANAGING PHYSICIAN WHICH RESULTED IN THE PUMP RUNNING OUT OF MEDICATION. THE PATIENT WAS RECEIVING ORAL MEDICATION TO OFFSET THE PUMP. THE PATIENT WAS HAVING ISSUES GETTING A NEW PHYSICIAN TO TAKE ON MANAGING THE PUMP; THE ISSUES WERE NOTED TO BE UNRELATED TO THE PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291300 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1