MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEU_ENTERRA_INS; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590)

Patient Problems Abdominal Pain (1685); Distress (2329); Malaise (2359); Sleep Dysfunction (2517); Foreign Body In Patient (2687)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: neu_unknown_lead, serial# unknown, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

A patient reported that in 2015 they had gastric bypass surgery and the healthcare provider (hcp) disconnected the implantable neurostimulator (ins) system and took the leads off of their old stomach, but did not hook them back up to the new stomach.They had been sick and suffering.Their stomach was only moving 40%, but they stated it had been since before implant.The patient mentioned they had not been asleep and up all night and then said they had been up for two days, sick.They said that the device was working fine and was somewhat helping.The patient then said the therapy never stopped helping because it was not hooked up to their new stomach.They had been trying to get it hooked back up for 22 months.It was noted that the patient was angry and upset.They were also waiting for an id card for their device and had not received one, yet.No further complications were reported/anticipated.Additional information from the patient stated they were still waiting for an id card.They stated that they felt like the "lead wires were wrapped around their muscle".They restated that when they wake up in the morning they have pain in their stomach.The patient was implanted in 2012, but not registered.The implanting hcp is no longer practicing in the us.No further complications were reported/anticipated.

• Brand Name: NEU_ENTERRA_INS
• 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: 7125706
• MDR Text Key: 95159946
• Report Number: 3007566237-2017-05207
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• 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?: No
• Date Manufacturer Received: 12/04/2017
• 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
• Patient Age: 53 YR