MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Nausea (1970); Necrosis (1971); Vomiting (2144); Discomfort (2330); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2023

Event Type  Injury  

Manufacturer Narrative

B.3.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.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.D.10: section d references the main component of the system.Other medical products in use during the event include: brand name lead; product id neu_unknown_lead; product type: 0200-lead.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.

Event Description

Goyal v, elshiekh m, drinnon k, puckett y.Small bowel ischemia secondary to gastric pacemaker wires¿a case report.J surg case rep.2023;2023(4):rjad174.Doi:10.1093/jscr/rjad174.Summary: gastric stimulator has been used as a surgical option for patients with gastroparesis refractory to medical management.Only one previous report of small bowel gangrene secondary to gastric pacemaker wires has been reported in the literature.Our patient was a 38-year-old woman with a history of systemic lupus erythematosus and history of total colectomy who underwent an uneventful open gastric pacemaker placement for idiopathic gastroparesis.Four months after the initial placement of the pacemaker, she presented to the emergency department with acute abdominal pain and was found to have gangrene of 140 cm of small bowel secondary to looping of gastric pacemaker wires around small bowel mesentery.She underwent uneventful small bowel resection and anastomosis with an ileorectal anastomosis.This case highlights the need for a high index of suspicion for this catastrophic complication in patients with gastric pacemakers.Reported event: patient with a history of systemic lupus erythematosus (sle) underwent gastric pacemaker implantation for idiopathic gastroparesis.Surgical history was signification for total colectomy with ileorectal anastomosis for lupus colitis.Three months after implant, the patient presented with complaints of frequent flipping of the battery in the subcutaneous pocket and underwent a revision of the pocket.One month after the pocket revision (4 months following initial procedure) they presented to the er with abdominal pain for 3 days associated with nausea and vomiting.When examined, their abdomen was tender to palpation over the epigastrium with guarding.Lab studies revealed very low white blood cell count t of 1118 per cubic millimeter (normal 4000¿11 000) and an elevated serum lactate level of 5.6 mmol per liter (normal 0.5¿2.2).Ct revealed diffuse bowel dilation with thickening, mesenteric fat stranding and air fluid levels and the gastric pacemaker wires appeared wrapped around the small bowel mesentery.She became acutely hypotensive and required fluid resuscitation and vasopressors.Patient underwent emergency laparotomy after initial fluid resuscitation.A long segment of the ileum was noted to be ischemic secondary to the gastric stimulator wires forming a 360-degree loop around the base of the mesentery.Gangrenous bowel was resected starting from a point 150 cm distal to the ligament of treitz all the way to her ileo-rectal anastomosis.A total of 140 cm long segment of distal small bowel was resected and the gastric stimulator was explanted.Patient¿s small bowel was left in discontinuity.She was taken back to the or 48 h later for a second look where the bowel looked healthy and a hand sewn anastomosis was performed between the small bowel and the rectal stump.Patient was left with a total length of 150 cm of small bowel that was connected to the rectum.Patient had an uneventful recovery and was discharged from the hospital.Over the next 2 years, patient went on to develop signs and symptoms of short gut syndrome that failed medical management and is currently being worked up for a small bowel transplant.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17254200
• MDR Text Key: 318452320
• Report Number: 2182207-2023-01280
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• 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: 06/28/2023
• 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; Life Threatening
• Patient Age: 38 YR
• Patient Sex: Female