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

Model Number 37800

Device Problems Malposition of Device (2616); Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Nausea (1970); Pain (1994); Scar Tissue (2060); Complaint, Ill-Defined (2331); Malaise (2359); Sleep Dysfunction (2517); No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of event is an approximation.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient was having the same symptoms and their healthcare professional (hcp) was trying to figure out what to do for scans.They had issues with their pancreas for a good two weeks, but was having bouts of feeling of punching in their stomach for almost a year.They were also having acid reflux and felt they were going to throw up.On (b)(6) 2018, the patient also reported that it was a daily struggle to eat, go to the bathroom, feel good, try to work, and have a social life.However, they also stated that they don't throw up, they could eat, and didn't have a feeding tube.They were seeking for a surgeon to do a sixth surgery.On (b)(6) 2018, the patient reported that they needed another surgery because their battery was in a bad spot again.It was noted that their quality of life was definitely better with the pacemaker, but they would just stay at home in pain.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer.It was reported that steps taken to try to resolve the patient¿s current symptoms and battery being in a bad spot included an ultrasound and x-ray of the pancreas; however, the issues had not been resolved and the patient needed surgery to move the pacemaker.It was noted that the cause of the battery being in a bad spot was that the surgeon put it up against the patient¿s belly button on nerves.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer.It was reported that the patient¿s current symptoms and battery being in a bad spot had not been resolved.The patient had been in bad pain for two years because two doctors put it in bad spots, and the patient had 2 surgeries in 4 months and was on their 5th surgery and only their 2nd battery.It was noted that the surgeon put it in a worse spot, dropped it down out of the patient¿s ribs, and shoved it over as far as they could into the patient¿s belly button and it had been on nerves the whole time.The patient couldn¿t sleep, bend over, pick up their grandbabies, and their pants hurt it.It was noted that the patient was told that because the patient was small, it was hard to put it in a good spot.The patient was told that they needed to move it to the right side now due to scar tissue, but it was noted that both sides were cut at one time, all the nerves cut, and that would be more pain.The patient suggested a smaller capsule pacemaker that is better and different so that they didn¿t keep having surgery over and over.It was noted that the cause of the battery being in a bad spot again was that the doctors were not educated enough.The patient really wanted the battery out of their body, but they get sick without it.No further complications were reported/anticipated.

• 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
• MDR Report Key: 7843753
• MDR Text Key: 119864509
• Report Number: 3004209178-2018-19839
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 58