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

Model Number 3116

Device Problem Battery Problem (2885)

Patient Problems Bacterial Infection (1735); Paresis (1998); Therapeutic Effects, Unexpected (2099); Hernia (2240); Complaint, Ill-Defined (2331); Constipation (3274)

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 consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient thought the battery was dead.It didn¿t do much difference in helping them anyways; they had other problems they didn¿t know about.They noted they were almost at the end of this road after 12 years and they were getting well.The patient stated the surgeon messed them up a little bit as they were going to do it laparoscopic, but they cut him from his naval to his sternum and they got a hiatal hernia a few months ago.The patient¿s doctor noted the hernia was okay and the patient diagnosed themselves.The patient was put on a bivisaid antibiotic, which only went after clostridium difficile (c diff).They had to do that twice and they just got off a 30-day regiment, noting it was gone and their stool was back to normal.The patient never had a problem going to the bathroom and had a gastric emptying test done and found that they were actually constipated.It was noted they had the stimulation turned down all the way as far as it could go and they tried 3-4 different settings years ago.The bottom of the patient¿s stomach was paralyzed.They noted they were going to have a colonoscopy and endoscopy on (b)(6) 2020.No 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 MED REL MEDTRONIC PUERTO RICO; 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: 9531448
• MDR Text Key: 173448719
• Report Number: 3004209178-2019-24545
• 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: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 12/04/2019
• 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): Required Intervention