BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3100014 · Received May 8, 2013

    Report

    Report Number
    3007566237-2013-01550
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 THE PATIENT WAS TOLD AN INCORRECT "ALARM DATE". THE PATIENT WAS INFORMED "A COUPLE MONTHS BACK" THAT THE ALARM DATE WAS THE ON THE THIRTIETH OF A MONTH WHEN IT WAS REALLY THE THIRD OF THE MONTH. A PUMP ALARM REPORTEDLY OCCURRED. IT WAS STATED, "THEY REVERSED THE NUMBERS, THE 03 AND THE 30". NO PATIENT SYMPTOMS WERE REPORTED. IT WAS NOT KNOWN WHAT MEDICATION THIS DEVICE SYSTEM HAD DELIVERED AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201683 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1