BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 5100576 · Received September 24, 2015

    Report

    Report Number
    1627487-2015-01328
    Event Type
    Injury
    Date Received
    September 24, 2015
    Report Date
    August 28, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COMPLAINED HE HAD TO CHARGE EVERY DAY TO MAINTAIN THERAPY AND HE STOPPED CHARGING AND USING HIS SCS STIMULATION SIX MONTHS AGO. THE PATIENT'S SCS IPG WAS EXPLANTED AND REPLACED. STIMULATION WAS REPORTEDLY RESUMED POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632041 EON RECHARGEABLE IPG, 16-CHANNEL SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 117333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 3262, SCS LEAD