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

Model Number 37800

Device Problems Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 09/21/2016

Event Type  malfunction  

Manufacturer Narrative

Section d information references the main component of the system.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A patient reported they had a replacement device and they were still having problems with it.The patient had increased pain.They stated that the incision was horizontal and vertical and with everything that they had read, it should have been laparoscopy but the they did an open procedure like they did the first time.Acute pain started too easy and then got worse again.It was hurting more every day.They said the doctors number is no where on the internet and they can't get a hold of them.The manufacturing representative (rep) was contacted and was able to help the patient.The implantable neurostimulator (ins) was indicated for gastric stimulation/gastrointestinal/pelvic floor.

Manufacturer Narrative

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

Event Description

No new information.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information from the patient reported that time finally resolved the patient after about eight months post-surgery.The healthcare provider (hcp) predicted six months.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 from the patient reported that they are still experiencing the pain and swelling on the day of the report.They did not know whether it was the surgery or the new device that was causing it.Their surgeon stated that it was probably "damaged cartilage", but they stated that there was no cartilage over the device.They went to see their surgeon and they stated that there was no infection and it was cartilage damage, although they did not do testing.They gave the patient 2 courses of steroids.The issue had not been resolved.They planned to see their gastrointestinal doctor to determine if the device was even working because their symptoms were not being helped.They wanted to see what they recommend.They stated that they had a sneaking suspicion that there were a couple of things going on, as they did not have problems with the original device or surgery, symptoms improved with 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6202423
• MDR Text Key: 63219520
• Report Number: 3004209178-2016-27142
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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,Followup,Followup,Followup,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• Date Device Manufactured: 07/26/2016
• 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 Age: 52 YR
• Patient Weight: 71