BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3053371 · Received April 11, 2013

    Report

    Report Number
    3007566237-2013-01216
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2004, WITHIN SIX MONTHS OF IMPLANT, THE CATHETER BROKE. ANOTHER CATHETER WAS SUCCESSFULLY IMPLANTED. HOWEVER, THE PHYSICIAN COULD NOT EXPLANT THE BROKEN CATHETER AND IT REMAINS IMPLANTED. IT WAS NOT KNOWN WHAT MEDICATION THE DEVICE SYSTEM DELIVERED AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156469 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention