MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEU_ENTERRA_INS; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

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

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 05/28/2018

Event Type  Injury  

Manufacturer Narrative

Please note that 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_enterra_ins, lot #: unknown, product type: implantable neurostimulator.Product id: neu_unknown_lead, lot #: unknown, product type: lead.Product id: neu_enterra_ins, lot #: unknown, product type: implantable neurostimulator.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Corvinus, f.M, heinrich, s., neumann, h., neumann, h., hadzijusufovic, e., babic, b., lang, h., grimminger, p.P.Minimal-invasive temporary gastric stimulation: a pilot study to predict the outcome of electronic gastric stimulation with the enterra system.Dig liver dis.2018.Doi: 10.1016/j.Dld.2018.05.023.Summary: gastroparesis (gp) is defined as delayed gastric emptying (ge) without any obstruction of the pylorus.It can be divided into idiopathic, diabetic, post surgical and rare causes.Electronic gastric stimulation (egs) ¿ enterra medtronic (tm)¿ is a part of gp therapy.Although its positive impact has been reported in open label trials, randomized controlled trials failed in demonstrating a positive outcome.The aim of this pilot study was to establish a reliable prediction for permanent gastric stimulation.Patients and procedure: 6 female patients underwent laparoscopic implantation of 2 temporary electrodes.The enterra (tm) system was connected and taped to the skin.Baseline and postoperative gastroparesis cardinal symptom index (gcsi), a validated index for gp therapy, was assessed.Response to egs was defined as a 50% decrease of baseline gcsi.Results: 4 of 6 patients responded to temporary egs.3 of 4 responders underwent permanent implantation.1 non-responder received a permanent enterra (tm) at another institution.After a median followup time of 9 months the responder group gcsi remained low, whereas the non-responder gcsi had increased.Moreover, the health care system was saved d 30,678.03 by this test stimulation concept.Conclusion: laparoscopic implantation of a temporary egs system predicts the outcome of permanent gastric stimulation and is cost-saving.Reported events: one patient with an ins did not respond to tegs but received a permanent device at another institution.Ten months after implantation the patient still complained of similar symptoms compared to their initial presentation.The device was already reprogrammed twice without showing any effect.Gcsi was 4 and had not decreased.A gastric venting tube was placed without any success.Occasionally the patient needed parenteral feeding.Their weight 10 months after implantation was (b)(6), she gained 2 kg, and bmi increased from 18.1 to 18.8.3.1.No specific device information was provided.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: NEU_ENTERRA_INS
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8151149
• MDR Text Key: 129927230
• Report Number: 3007566237-2018-03560
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention