MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

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

Patient Problem Insufficient Information (4580)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, lot#: unknown, product type: lead.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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastroparesis.It was reported that in¿(b)(6) of 2018 (never registered) patient received the enterra implant to treat gastroparesis however they only experienced problems with the implant from the beginning.Patient said that the neurostimulator was popping out of their stomach area so in (b)(6) 2019 (end of (b)(6)) the surgeon performed revision of the neurostimulator and patient said they think that the surgeon pushed too hard and the leads became entangled with the small intestine.Patient said that on (b)(6) 2019 went to the er due to the continual pain since the surgery and they did perform a scan and that is when it was discovered that the leads were entangled with the small intestine.Patient said that they was placed into icu and had immediate surgery in which the neurostimulator was removed however because the leads were entangled, about 1./ of their small intestine was removed.Patient said that as a result of this emergency surgery, they have not had a good quality of life and has found a healthcare team in washington, dc that will perform a small intestine transplant and is calling manufacturer as a resource for funding options for this surgery.The patient's relevant medical history included patient said that prior to implant that patient lost her large intestine.

• 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: 12628234
• MDR Text Key: 276354308
• Report Number: 2182207-2021-01793
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• 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