MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problems Unstable (1667); Positioning Problem (3009)

Patient Problems Wound Dehiscence (1154); Foreign Body Reaction (1868); Pain (1994); Pocket Erosion (2013); Therapeutic Effects, Unexpected (2099); Impaired Healing (2378); Fluid Discharge (2686)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

Section d information 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 patient reported they got a new implantable neurostimulator (ins) due to normal battery depletion.The incision that was made, never fully healed and was draining.Later, the hole that had been draining was bigger, and they could see the edge of the ins through the skin.Their surgeon said they were not looking at the edge.The patient then went to the emergency room (er) and the healthcare provider (hcp) there cut out an area that had grown in where the incision had not gone in together right.An even bigger hole was made, and they could see more of the ins, in order to stitch it together.The patient stated that one of the stitches busted open and a piece of the ins was coming back through the abdomen and was sticking out of the abdomen, at the time of the report.The patient would follow up with their hcp.The ins indication for use was not clear at the time of the report.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported the ins was removed on (b)(6) due to the body rejecting the device by pushing it out and pushing the incision out; the leads were cut and left in the abdomen well.Since the removal, the patient had been having pain in the ins area and was wondering if the leads could be causing the pain.Indication for use was gastric stimulation.

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.

• 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: 6274149
• MDR Text Key: 65630096
• Report Number: 3007566237-2017-00253
• 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,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2017
• Date Device Manufactured: 08/09/2016
• 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): Required Intervention
• Patient Age: 41 YR