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

Model Number 37800

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pneumonia (2011); Sepsis (2067); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Complaint, Ill-Defined (2331); Constipation (3274)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient reported that their gastrointestinal healthcare provider (hcp) performed a biopsy or endoscopy and told the patient that they still were not putting food through fast enough.They always had food in their stomach which left they open for "infection or illness etc." this event occurred (b)(4) 2017 the patient thought that either the managing hcp did not set the "speed" at the proper setting when the device was implanted, or the device itself faulty.They were on a liquid diet for 7 days, and there was still food that was turning black.The patient's vomiting was also increasing.They were still taking vitex and protonix.It was indicated that the patient ended up getting pneumonia and sepsis because they hadn't had a bowel movement.They mentioned that this was granted that they were only taking colace in the hospital whereas when they were at home, they were on "zeps." even with that, it was not moving or giving them a bowel movement every day like it used to.Now it was every 2 or 3 days again.The patient stated that the device was implanted because they were vomiting between 8-12 hours a day, at least 3 days a week.It was because their stomach was moving "like 2 every 350 hours or something 256 hours." it was noted that the patient was an amputee with possibly "cipd or atypical als." the patient planned to follow-up with the current managing hcp.There were no further complications reported as a result of this event.The indication for use was gastric stimulation.

• 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: 7491262
• MDR Text Key: 107497642
• Report Number: 3004209178-2018-10267
• 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
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2018
• Date Device Manufactured: 07/06/2016
• 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 Outcome(s): Life Threatening
• Patient Age: 51 YR