MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problem High impedance (1291)

Patient Problems Abdominal Pain (1685); Abscess (1690); Erosion (1750); Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Complaint, Ill-Defined (2331); Test Result (2695); No Code Available (3191)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id neu_unknown_lead; product type lead.Product id neu_unknown_lead, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead ; product id: neu_unknown_lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient in a clinical study.It was reported that the patient presented to the er with abdominal pain and fever.A ct scan was done, which showed an intra-abdominal abscess with the gastric stimulator leads in connection with the abscess.It was noted that the patient had the gastric stimulator placed about six years ago at another hospital and was not seen by the hcp or under the hcps care prior to this event.The hcp took the patient for emergent exploration and found the leads had eroded within the stomach and a large intra-abdominal abscess; the abscess was drained.It was noted that the small bowel was severely thickened and required resection as well.The hcp did not see any small bowel injuries or enterotomies, and noted that it was just severely inflamed and likely due to the adjacent abscess.The patient was currently in the hospital on iv antibiotics.It was noted that the patient was not febrile, but wbc remained elevated, and the patient was npo with ngt in place until return of bowel function.During the procedure, the generator was tested and the impedance was greater than 800; the device was turned off.There was evidence of a dense inflammatory process in the left upper quadrant.The abscess cavity was entered bluntly and purulence was cultured and evacuated.The leads were noted to be travelling through t he process; the leads were followed superiorly to the entry point of the stomach, which required opening the omentum along the length of the path taken by the leads.Upon viewing the stomach, the leads were noted to be intraluminal and there was approximately 1 cm gastrotomy from this erosion; the leads were removed from the lumen of the stomach.The small bowel was eviscerated and then run along its entirety.The proximal jejunum was severely thickened and an approximately 10 cm area was resected using a gia blue load.A small bowel anastomosis was then done and an end-to-end functional side-to-side fashion using a gia blue load stapler for the anastomosis and 2 layer closure for the common enterotomy using vicryl and silk.The anastomosis was widely patent, the mesenteric defect was closed with silk, and there was a neither distal jejunal thickening but not severe.No enterotomies were noted and this was left in tact.The leads were transected with scissors to allow easy removal from within the abdomen, there was no evidence of infection within the pocket itself; however, the capsule was removed.A drain was placed in the left upper quadrant and secured in place with nylon, hemostasis was ensured, the patient was taken to recovery in good condition, and all counts were correct x2.It was noted that the event was related to the device and was ongoing; the patient was currently in the hospital on iv antibiotics.No further complications were reported/anticipated.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from manufacture representative (rep) reported the cause of the lead having eroded within the patient¿s stomach and abscess was unable to be determined.The hcp noted the cause of the impedance being greater than 800 was the lead erosion into the stomach.The hcp noted the gastric stimulator and leads were sent to pathology at the time of the operation.There were no further complications that have been reported as a result of this event.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7870487
• MDR Text Key: 120099776
• Report Number: 3007566237-2018-02733
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 09/12/2018
• Supplement Dates Manufacturer Received: 09/17/2018
• Supplement Dates FDA Received: 09/20/2018
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 84