MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Fistula (1862); Paresis (1998); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 06/01/2015

Event Type  Injury  

Manufacturer Narrative

Suspect medical device references the main component of the system.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 healthcare provider (hcp) reported that a patient had worsening of symptoms.The hcp stated that the patient was admitted the day prior to the report, then said a couple of days prior to the report, primarily for a diabetic foot ulcer that was infected, but also for the worsening of their gastroparesis symptoms.They speculated that the worsening of symptoms was due to being on antibiotics, but wanted to find out if the device was working appropriately.The patient was also having surgery the day after the report because they had a j-tube placed for feeding around the same time as the implantable neurostimulator (ins) and it was removed 18 months ago, but has not closed up.They did imaging and there may be foreign bodies that caused a fistula to form.The symptoms have been well controlled since implant in 2012 and they have not had a lot of recent adjustments.The ins indication for use was not clear at the time of the report.

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6241589
• MDR Text Key: 64489082
• Report Number: 3007566237-2017-00095
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2016
• 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): Hospitalization