MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Malposition of Device (2616)

Patient Problems Dysphagia/ Odynophagia (1815); Hemorrhage/Bleeding (1888); Nausea (1970); Pain (1994); Complaint, Ill-Defined (2331); Malaise (2359); No Code Available (3191)

Event Date 09/15/2013

Event Type  Injury  

Event Description

Additional information received reported that the event occurred in 2013.The intervention needed was that the stimulator was repositioned.It was noted that the patient outcome was partial improvement in pain.

Event Description

It was reported that the patient had their device implanted on 2011-(b)(6).In (b)(6) 2013, they had an ercp (endoscopic retrograde cholangiopancreatography) done and their pancreas cleaned out.Ten days later their doctor repositioned their stimulator because they thought it was in the wrong position from the initial implant and it was hurting the patient a lot.The doctor who did the surgery told the patient there was a probable chance of infection or cutting the lead during the repositioning procedure.Additional information has been requested, but was not available as of the date of this report.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 435135, serial# (b)(4), implanted: 2011-(b)(6), product type lead, product id 435135, serial# (b)(4), implanted: 2011-(b)(6), product type lead.(b)(4).

Manufacturer Narrative

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

Event Description

No new information was reported (the patient's weight was reported).

Manufacturer Narrative

Product id 435135 (b)(4) implanted: (b)(6)2011 product type lead product id 435135 (b)(4) implanted: (b)(6)2011 product type lead due to imdrf harmonization, results, methods, and conclusion codes were updated.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 had their gallbladder removed and their pancreas had gallstones and blood in it.They were 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 2018-08-16, 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.No device issues or further complications were reported or anticipated.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; road 31, km. 24, hm 4; ceiba norte industrial park; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 3759487
• MDR Text Key: 4372016
• Report Number: 3004209178-2014-07523
• 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,Health Professional,consumer,health profess
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/03/2018

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 Expiration Date: 11/28/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2014
• Initial Date FDA Received: 04/18/2014
• Supplement Dates Manufacturer Received: Not provided; 08/14/2018; 11/20/2018
• Supplement Dates FDA Received: 05/14/2014; 08/30/2018; 12/03/2018
• Date Device Manufactured: 06/07/2011
• 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
• Patient Age: 46 YR
• Patient Weight: 54