MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA NEUROSTIMULATOR, UNKNOWN; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Unstable (1667)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Nausea (1970); Pain (1994); Vomiting (2144); Hernia (2240); Complaint, Ill-Defined (2331); Obstruction/Occlusion (2422); Cognitive Changes (2551); Electric Shock (2554)

Event Type  Injury  

Event Description

Brody, f., zettervall, s.L., richards, n.G., garey, c., amdur, r.L., saddler, a., ali, m.A.Follow-up after gastric electrical stimulation for gastroparesis.Journal of the american college of surgeons.2015;220(1):57-63.Doi: 10.1016/j.Jamcollsurg.2014.10.001 summary: gastric electrical stimulation (ges) is used to treat medically refractory gastroparesis.However, there are few large series with o utcomes beyond 12 months.This study reports surgical outcomes of ges for patients up to 8 years receiving treatment from a single institution.A prospective database was reviewed from 2003 to 2013 for patients undergoing ges.Baseline patient characteristics were recorded, including age, sex, cause of gastroparesis, gastric emptying, and hgb a1c.Outcomes variables included nutrition supplementation, additional operations, 30-day morbidity, and mortality.Pre- and postoperative pain and function scores are analyzed over time using generalized estimating equations.Patient outcomes in terms of reoperation rates and types of operations are also reviewed.Seventy-nine patients underwent ges with a mean +/- sd age of 43 +/- 11 years and a bmi of 27 +/- 8 kg/m2.Symptom scores were available for 60 patients: 60 patients at baseline, 52 patients at 1 year, 14 patients during years 2 to 3, and 18 patients during years 4 to 8.Symptom scores decreased considerably in all categories.At 1-year follow-up, 44% and 31% of patients had at least a 25% reduction in symptom distress for functional and pain symptoms, respectively.Preoperatively, 9 patients required nutrition supplem entation.After implantation, 34 (43%) patients underwent additional operations, with a mean of 2.15 operations per patient.Generator-related causes were the most common indication for reoperation, including battery exchanges and relocation.Other operations included 8 gastrectomies and 7 median arcuate ligament releases.Postoperatively, 4 patients required supplemental nutrition.There were no 30-day mortalities, but 11 patients died during the study period.Gastric electrical stimulation was significantly associated with reductions in both functional and pain-related symptoms of gastroparesis.Patients who undergo ges have a high likelihood of additional surgery.Reported events: 1 patient with gastroparesis and multiple previous operations had two operations performed 4 and 5 years after implant for non-resolving small bowel obstructions.Two patients with gastroparesis underwent lysis of adhesions for obstruction operations after neuromodulation.Three generator relocation surgeries were required by 8 patients with gastroparesis to alter generator location or due to flipping.It was noted that generator relocation was performed for symptoms of pain or shocking at the generator site, which resolved after relocation.Eight patients with gastroparesis underwent gastrectomies for refractory symptoms of nausea and vomiting after neuromodulation.After undergoing a diagnostic celiac artery ultrasound and a confirmatory aortogram, 7 patients with gastroparesis underwent median arcuate ligament release operations due to persistent abdominal pain after neuromodulation.Nine patients with gastroparesis underwent feeding tube related operations due to persistent symptoms after neuromodulation.Three patients with gastroparesis underwent hernia-related operations after neuromodulation.Two patients with gastroparesis required a return to the operating room within 30 days for incarcerated hasson port-site hernias.Two patients with gastroparesis underwent generator explant due to psychiatric illness.Further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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.Concomitant: product id neu_enterra_ins, lot# unknown, product type implantable neurostimulator.(b)(4).

• Brand Name: ENTERRA NEUROSTIMULATOR, UNKNOWN
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4460629
• MDR Text Key: 5324408
• Report Number: 3007566237-2015-00214
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2015

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: 01/07/2015
• Initial Date FDA Received: 01/28/2015
• 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): Life Threatening; Required Intervention
• Patient Age: 00043 YR