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

Model Number 3116

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bacterial Infection (1735); Dehydration (1807); Pain (1994); Vomiting (2144); Electric Shock (2554); Weight Changes (2607); Insufficient Information (4580)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the patient said 4 to 5 month ago a manufacturer representative (rep) was supposed to check the device but canceled and never rescheduled.Patient said they are doing "really bad" and can't get the covid shot because they think the patient has c.Differential again.Patient said they are going to the emergency room (er) every 3 weeks for iv therapy and can't keep water down.Patient had a colonoscopy and they didn't find anything.Patient said every once in awhile they get a sharp pain and said it was a sharp shock every once in awhile at the bottom left side of implant the patient called back and stated the same symptoms.The patient stating their weight is fluctuating up and down by 20 pounds.The patient cannot go to the healthcare provider (hcp) office because its too far and is wanting a manufacturer representative (rep) come check the device.Last time the patient went to see the hcp was 5 to 6 years ago and was told the settings were too low.Agent did not ask about the circumstances that led to the reported issue.The patient was redirected to their healthcare provider to further address the issue.

• 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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11334921
• MDR Text Key: 232319805
• Report Number: 3004209178-2021-02706
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2011
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Date Device Manufactured: 11/10/2009
• 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): Other
• Patient Age: 65 YR