MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Diarrhea (1811); Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Nausea (1970); Vomiting (2144); Bowel Perforation (2668); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2020

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical product(s): product id neu_enterra_ins, product type implantable neurostimulator; product id neu_enterra_ins, product type implantable neurostimulator; product id neu_unknown_lead, product type lead.Device information references the main component of the system.Other relevant device(s) are: product id: neu_enterra_ins, unknown product id: neu_enterra_ins, product id: neu_unknown_lead.Please note that event date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Condon, a., patel, a., shah, n., et al.(2020).Gastric electrical stimulators causing erosion through the colonic wall.Acg case reports journal.2020;7:e00313.Doi:10.14309/crj.0000000000000313 summary: gastroparesis is a chronic motor disorder of the stomach characterized by the demonstration of delayed gastric emptying without obstruction and a grouping of symptoms including nausea, vomiting, early satiety, postprandial fullness, bloating and abdominal pain.When conservative medical management is not effective,gastric electrical stimulation is an effective alternative.Gastric electrical stimulation, in general, has had a low complication rate as of yet, with the most common being infection of the implanted device.We present a complication in which the gastric electrical stimulator electrodes eroded through the colonic wall.Reported event: 1.       male patient, aged 59 years old had a placement of the gastric electrical stimulator in july 2010.Patient has required up to 4 revisions.Patient¿s multiple hardware infections with device exchanges have complicated thir course, including the most recent infection in 2017, resulting in the total replacement of the gastric electrical stimulator and placement of tobramycin stimulan beads.Patient¿s most recent revision was in august 2018, just 1 month before presenting for a battery replacement.Most recently, about 7 weeks after their last replacement, patient presented with worsening of gastroparesis symptoms, consistent with 2 other reported presentations of gastric electrical stimulator erosion, which penetrated the gastric mucosa.During the patient¿s hospitalization, they presented with left-sided intermittent abdominal pain for 1 week, along with erythema around the battery site with purulent drainage and associated nausea, vomiting, and diarrhea.An abdominal computed tomography scan showed gastric stimulator leads extending into the transverse colon and a small amount of fluid or soft tissue thickening around the stimulator power pack.This prompted a colonoscopy, which demonstrated 2 wires from the gastric stimulator piercing the distal transverse colon approximately 60 cm from the anus.There was also a disk-like structure attached to the distal part of the wire.After 3 days¿ treatment with daptomycin and zosyn, the implanted gastric stimulator was surgically removed, and recovered without complications.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16618888
• MDR Text Key: 312123293
• Report Number: 2182207-2023-00546
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENTERRA_INS
• Device Catalogue Number: NEU_ENTERRA_INS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• 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
• Patient Age: 59 YR
• Patient Sex: Male