BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 8126166 · Received December 3, 2018

    Report

    Report Number
    1627487-2018-12564
    Event Type
    Injury
    Date Received
    December 3, 2018
    Date of Event
    July 1, 2018
    Report Date
    December 3, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED. AS SUCH, THE PATIENT WAS WITHOUT STIMULATION FOR APPROXIMATELY 2 MONTHS AND THE IPG WAS INOPERABLE. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE IPW WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL. REPORTEDLY, THE PATIENT HAD EFFECTIVE THERAPY FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965695 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3866480

    Patients

    Seq Age Sex Outcome Treatment
    1 Other