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    Enterra Medical, Inc.

    Manufacturer
    🇺🇸 United States·1 Importer

    ENTERRA MEDICAL, INC.

    FDA registration
    ENTERRA MEDICAL, INC.·1 product·🇺🇸 United States

    Enterra ReliaStim Unipolar Lead

    FDA UDI
    Enterra Medical, Inc.·00850045965204·The ReliaStim lead is a sterile, single-use dev...

    ENTERRA II IPG

    FDA Adverse Event
    Malfunction ·ENTERRA MEDICAL, INC·Product code LNQ·March 18, 2024

    Medtronic Enterra Therapy, Gastric Electrical Stimulation System, consisting of model 3116 Enterra Therapy Neurostimulator and model 4351 Unipolar Intramuscular Lead. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Neurostimulator (implantable neurostimulator or INS) is a multiprogrammable device designed to deliver therapy through gastric electrical stimulation when connected to a lead system. Humanitarian Device: Authorized by Federal Law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LNQ·August 25, 2009

    ENTERRA II IPG

    FDA Adverse Event
    Death ·ENTERRA MEDICAL, INC.·Product code LNQ·July 10, 2024

    ENTERRA II IPG

    FDA Adverse Event
    Injury ·ENTERRA MEDICAL, INC.·Product code LNQ·August 23, 2024

    ENTERRA II IPG

    FDA Adverse Event
    Malfunction ·ENTERRA MEDICAL, INC.·Product code LNQ·July 31, 2024

    ENTERRA II IPG

    FDA Adverse Event
    Malfunction ·ENTERRA MEDICAL, INC.·Product code LNQ·July 11, 2024

    ENTERRA II IPG

    FDA Adverse Event
    Injury ·ENTERRA MEDICAL, INC.·Product code LNQ·July 16, 2024

    ENTERRA II IPG

    FDA Adverse Event
    Injury ·ENTERRA MEDICAL, INC.·Product code LNQ·August 22, 2024

    ENTERRA II IPG

    FDA Adverse Event
    Injury ·ENTERRA MEDICAL, INC.·Product code LNQ·August 29, 2024

    ENTERRA II IPG

    FDA Adverse Event
    Malfunction ·ENTERRA MEDICAL, INC.·Product code LNQ·September 19, 2024

    ENTERRA II IPG

    FDA Adverse Event
    Injury ·ENTERRA MEDICAL, INC.·Product code LNQ·September 24, 2024

    ENTERRA II IPG

    FDA Adverse Event
    Injury ·ENTERRA MEDICAL, INC.·Product code LNQ·July 10, 2024

    ENTERRA II IPG

    FDA Adverse Event
    Injury ·ENTERRA MEDICAL, INC.·Product code LNQ·August 9, 2024

    ENTERRA II IPG

    FDA Adverse Event
    Injury ·ENTERRA MEDICAL, INC.·Product code LNQ·September 4, 2024

    ENTERRA II IPG

    FDA Adverse Event
    Malfunction ·ENTERRA MEDICAL, INC.·Product code LNQ·July 16, 2024

    ENTERRA II IPG

    FDA Adverse Event
    Injury ·ENTERRA MEDICAL, INC.·Product code LNQ·August 8, 2024

    ENTERRA II IPG

    FDA Adverse Event
    Injury ·ENTERRA MEDICAL, INC.·Product code LNQ·August 23, 2024