BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 3242343 · Received July 23, 2013

    Report

    Report Number
    3007566237-2013-02440
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8840, SERIAL# UNKNOWN: PRODUCT TYPE PROGRAMMER; PHYSICIAN PRODUCT ID 8870: PRODUCT TYPE SOFTWARE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANT A PUMP MEMORY ERROR OCCURRED. NO VALID PUMP AND CATHETER. THE CAUSE OF THE ERROR WAS INDICATED AS OLD SOFTWARE CARD IN THE PROGRAMMER. THERE WAS NO VALID CATHETER SO UNPROGRAMMABLE AND THE HCP WAS UNABLE TO PROGRAM THE PUMP AS THERE WAS NO DATA. AT THAT TIME THERE WERE NO CHANGES TO THE PUMP AND A NEW SOFTWARE CARD WAS BEING OBTAINED. ADDITIONAL INFORMATION LATER RECEIVED REPORTED THE ISSUE WAS RESOLVED. IT WAS ALSO REPORTED ALL WAS ¿FINE¿ WITH PATIENT AND A NEW SOFTWARE CARD WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342430 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR