MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR; INTESTINAL STIMULATOR

Model Number NEU_INS_STIMULATOR

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Unspecified Infection (1930); Seroma (2069)

Event Date 06/21/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.Concomitant medical products: product id: neu_ins_stimulator, product type: implantable neurostimulator.Other relevant device(s) are: product id: neu_ins_stimulator.If information is provided in the future, a supplemental report will be issued.[(b)(4)].

Event Description

Sterman, j., cunqueiro, a., dym, r.J., spektor, m., lipton, m.L., revzin, m.V., scheinfeld, m.H.Implantable electronic stimulation devices from head to sacrum: imaging features and functions.Radiographics.2019.39(4): 1056-1074.Doi: 10.1148/rg.2019180088.Summary: electronic stimulation devices are implanted in various locations in the body to decrease pain, modulate nerve function, or stimulate various end organs.The authors describe these devices using a craniocaudal approach, first describing deep brain stimulation (dbs) devices and ending with sacral nerve stimulation (sns) devices.The radiology-relevant background information for each device and its imaging appearance are also described.These devices have a common design theme and include the following components: a pulse generator that houses the battery and control electronics, an insulated lead or wire that conveys signals to the last component, which is an electrode that contacts the end organ and senses and/or acts on the end organ.Dbs electrodes are inserted into various deep gray nuclei, most commonly to treat the symptoms of movement disorders.Occipital, trigeminal, and spinal nerve stimulation devices are used as second-line therapy to control craniofacial or back pain.For cardiac devices, the authors describe two newer devices, the subcutaneous implantable cardioverter defibrillator and the leadless pacemaker, both of which avoid complications related to having leads threaded through the venous system.Diaphragmatic stimulation devices stimulate the phrenic nerve to restore diaphragmatic movement.Gastric electrical stimulation devices act on various parts of the stomach for the treatment of gastroparesis or obesity.Finally, sns devices are used to modulate urinary and defecatory functions.Common complications diagnosed at imaging include infection, hematoma, lead migration, and lead breakage.Understanding the components, normal function, and normal imaging appearance of each device allows the radiologist to identify complications.Reported events: a fluid collection around a gastric pacemaker in a (b)(6)-year-old woman with a history of gastroparesis (figure 18).Two weeks after implantation, the patient had erythema and drainage at the surgical site.Gray-scale and color doppler us images show a subcutaneous fluid collection (*) superficial to the pulse generator.A seroma was the favored diagnosis owing to the lack of hyperemia.Antibiotics were still administered empirically, but the fluid was not drained.The patient¿s symptoms resolved.A unilateral interstim system in a (b)(6)-year-old woman with urinary incontinence (figure 20).Initial radiograph shows the lead connectors (arrow) oriented superiorly.Follow-up lateral radiograph obtained 2 months later shows that the connectors (arrow) are directed to the right.Although the electrode position was unchanged, the pulse generator rotation may indicate a loose pocket or twiddling, in which the patient consciously or subconsciously spins the generator in a capacious pocket and may cause lead retraction.The device was repositioned by the clinician and placement was confirmed at radiography (not shown).No specific device information provided.

• Brand Name: NEU_INS_STIMULATOR
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9108709
• MDR Text Key: 164719660
• Report Number: 3007566237-2019-02008
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention