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

Model Number 3116

Device Problem Overheating of Device (1437)

Patient Problems Fall (1848); Burning Sensation (2146); Dizziness (2194); Abdominal Distention (2601)

Event Type  malfunction  

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).

Event Description

It was reported that the patient had a searing pain around their device and feel severely nauseated.Additional information received reported that the patient had a burning sensation around her implant.It was noted that the patient had been falling since it started.It was noted that the patient also felt dizzy, severe bloating, and nausea.It was further noted that the swelling decreased but that the burning was 3 times worse.It was noted that there was no known accident or incident related to this complaint.It was further noted that the patient's status was unknown.

• 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: 5170538
• MDR Text Key: 29325177
• Report Number: 3004209178-2015-21313
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• 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: 07/22/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2013
• Date Device Manufactured: 01/16/2011
• 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