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

Model Number 37800

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Weakness (2145); Therapeutic Response, Decreased (2271); Electric Shock (2554); Weight Changes (2607)

Event Date 06/01/2017

Event Type  malfunction  

Event Description

A patient reported that the implantable neurostimulator (ins) was shocking them at the bottom left corner of the box.They went to the healthcare provider (hcp) on (b)(6) 2017 and the hcp turned the device off and the shocking stopped.About 5 hours after turning stimulation off, they went back to being sick.Their stomach was extended like they were (b)(6) pregnant.The patient went back to the hcp on (b)(6) 2017, almost a week later, and they were already dropping weight and had skin hanging, and they were sick again.Prior to the appointment on (b)(6) 2017, they noticed they were weak, sick and dropping weight.During the appointment with the hcp, they turned the device back on and the device was back to shocking them within an hour.They said that the hcp told them they would not replace the device because it would just malfunction again.The patient said that their hcp just wants to cut the bottom part of their stomach muscle and do all "this other stuff.They do not want that because they know how much longer after they do that their intestines start messing up and would have to have a colostomy bag.The hcp said that they cannot replace the device because they already replaced the device.The patient said they are not going to have the hcp cut them wherever they want and cause more damage.They requested a new hcp.No further complications were reported.

Manufacturer Narrative

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

• 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: 6721638
• MDR Text Key: 80421617
• Report Number: 3004209178-2017-15042
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2017
• Date Device Manufactured: 01/29/2015
• 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: 40 YR