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

Model Number 3116

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Diarrhea (1811); Swelling (2091); Tingling (2171); Complaint, Ill-Defined (2331); Abdominal Distention (2601)

Event Date 12/31/2013

Event Type  malfunction  

Event Description

It was reported that where the leads were attached, was ¿sucking the patient¿s stomach in and then pushing it out.¿ the reporter stated that one could see the patient¿s stomach being sucked in and then pushed out through his clothes.The reporter stated that this suddenly started three days ago, but it was not constant.The reporter also stated that the patient¿s stomach tingles, which also started three days ago.It was also reported that the morning of the report the patient had extreme diarrhea, ¿like water, like he had a virus, but did not.¿ the reporter also stated that the patient¿s stomach could be heard making noises and bubbling.At the time of the report, the patient¿s stomach and colon were swollen.The patient had no falls or trauma.The patient also had the device turned up and down because of excess bloating.Additional information was requested, but was not available as of the date of this report.Refer to manufacturing report #3004209178-2014-00980 as the patient also issues related to the therapeutic benefit of the device.

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3587864
• MDR Text Key: 4140151
• Report Number: 3004209178-2014-00987
• 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
• Report Date: 01/03/2014

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 Expiration Date: 12/28/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2014
• Initial Date FDA Received: 01/22/2014
• Date Device Manufactured: 06/29/2011
• 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 Age: 00052 YR