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    MEDTRONIC NEUROMODULATION

    FDA registration
    MEDTRONIC NEUROMODULATION·26 products·🇺🇸 United States

    MEDTRONIC NEUROMODULATION

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code LGW·December 1, 2017

    MEDTRONIC NEUROMODULATION

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·January 29, 2014

    MEDTRONIC NEUROMODULATION

    FDA Adverse Event
    MEDTRONIC·Product code EZW·April 11, 2019

    MEDTRONIC NEUROMODULATOR INTERSTIM SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·September 8, 2025

    NALU PERIPHERAL NERVE STIMULATOR

    FDA Adverse Event
    Injury ·NALU MEDICAL·Product code GZF·September 8, 2025

    MEDTRONIC NEUROMODULATION IMPLANTED INFUSION PUMP

    FDA Adverse Event
    Other ·Product code LKK·May 9, 2008

    INDURA

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·February 6, 2008

    SYNCHROMED

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·February 6, 2008

    INDURA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·February 6, 2008

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·May 2, 2012

    Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·April 6, 2016

    InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·June 19, 2019

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code LGW·August 12, 2023

    Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the pump, catheter,r and catheter accessories The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of drugs or fluids:

    FDA Enforcement
    Class I ·Terminated·Medtronic Neuromodulation·July 3, 2013

    SPRINT QUATTRO SECURE S MRI SURESCAN

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·December 26, 2024

    Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The drug is stored in the pump reservoir. Per a programmed prescription, the drug moves from the pump reservoir, through the pump tubing, catheter port, and catheter, to the infusion site. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids:

    FDA Enforcement
    Class I ·Terminated·Medtronic Neuromodulation·July 3, 2013

    INTERSTIM X

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·May 12, 2026

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code LGW·August 12, 2023

    Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to turn therapy ON or OFF; maximal control allows the patient to select from different therapies and adjust the parameters with in the set therapy limits.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code EZW·May 12, 2008