BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 3922926 · Received July 9, 2014

    Report

    Report Number
    3007566237-2014-01909
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8703, LOT# J93122336, IMPLANTED: (B)(6) 1993, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE 90S THE PATIENT WENT THROUGH WITHDRAWAL BECAUSE OF A BREAK IN THE CATHETER. A REVISION WAS DONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399254 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention