MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Sepsis (2067); Vomiting (2144); Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 03/25/2022

Event Type  Injury  

Event Description

Samaan, j.S., toubat, o., alicuben, e.T., dewberry, s., dobrowolski, a., sandhu, k., zehetner, j., lipham, k.Gastric electric stimulator versus gastrectomy for the treatment of medically refractory gastroparesis.Surg endosc.Doi: 2022.10.1007/s00464-022-09191-0.Summary: gastric electrical stimulation (ges) and laparoscopic gastrectomy (lg) are known therapeutic options for medically refractory gastroparesis (mrg) although there are limited data comparing their outcomes.We aim to compare clinical outcomes between patients undergoing ges vs upfront lg for the treatment of mrg while examining factors associated with ges failure and conversion to lg.We retrospectively analyzed 181 consecutive patients who underwent ges or lg for mrg at our institution from (b)(6) 2003 to (b)(6) 2017.Data collection consisted of chart review and follow-up telephone survey.Statistical analysis utilized chi-squared, anova, and multivariable logistic regression.Overall, 130 (72%) patients underwent ges and 51 (28%) lg as primary intervention.Ges patients were more likely to have diabetic gastroparesis (ges 67% vs lg 39%, p = 0.001), while primary lg patients were more likely to have post-surgical gastroparesis (ges 5% vs lg 43%, p = 0.001).Postoperatively, primary lg patients had higher rates of major in-hospital morbidity events (ges 5% vs lg 18%, p = 0.017) and longer hospital stays (ges 3 vs lg 9 days, p = 0.001).However, over a mean 35-month follow-up period, there were no differences in the rates of major morbidity, readmissions, or mortality.Multivariable regression analysis revealed patients undergoing ges as a primary intervention were less likely to report improvement in symptoms on follow-up compared to primary lg patients or 0.160 (95% ci 0.048¿0.532).Additionally, patients who converted to lg from ges were more likely to have post-surgical gastroparesis as the primary etiology.Conclusion ges as a first-line surgical treatment of mrg was associated with worse outcomes compared to lg.Postsurgical etiology was associated with an increased likelihood of ges failure, and in such patients, upfront gastrectomy may be a superior alternative to ges.Further studies are needed to determine patient selection for operative treatment of mrg.Reported events: 7 patients experienced in-hospital morbidity.3 patients experienced a wound infection.One patient experienced a cardiac event/mi.One patient experienced sepsis.5 patients experienced a ges infection.2 patients experienced a small bowel obstruction.No specific device information provided.

Manufacturer Narrative

Concomitant medical products: product id: neu_interstim_ins; product type: implantable neurostimulator.Other relevant device(s) are: product id: neu_interstim_ins.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.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device for pli100 in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements stipulated in 21 cfr 803.B.3.Of initial report: please note that this 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.B.5.Of initial report: it was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.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.

Manufacturer Narrative

D4: device model # updated.Continuation of d10: product id neu_enterra_ins lot# unknown serial# implanted: explanted: product type implantable neurostimulator product id neu_enterra_ins lot# unknown serial# implanted: explanted: product type implantable neurostimulator product id neu_enterra_ins.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.

• 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: 14881309
• MDR Text Key: 295110349
• Report Number: 2182207-2022-01226
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 12/21/2022; 06/13/2023
• Supplement Dates FDA Received: 12/21/2022; 06/13/2023
• 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