MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Malaise (2359)

Event Type  malfunction  

Manufacturer Narrative

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 consumer reported that they were reading online that people were saying the implantable neurostimulator (ins) providing therapy for gastrointestinal issues "kind of goes haywire or goes rogue on them".They have to have it turned down immediately.The consumer stated that people are complaining that they ate fried chicken and then they did not feel good.The consumer said they found the information on a blog site and there were 2 or 3 people on that blog that had complained.They did internet searches as well.They did not provide any more specific details.The consumer also inquired about device management when their healthcare provider is not available.No further complications were reported/anticipated.

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 NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6910948
• MDR Text Key: 88126668
• Report Number: 3007566237-2017-04158
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENTERRA_INS
• Device Catalogue Number: NEU_ENTERRA_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 06/28/2018
• 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