MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 4351-35

Device Problem Impedance Problem (2950)

Patient Problem Internal Organ Perforation (1987)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.(b)(4).

Event Description

The manufacturers' representative (rep) reported that the patient went to the clinic for a follow up check-up at the beginning of (b)(6) 2015.At this time, the impedance was showing out of range.She was then taken back to the operating room on (b)(6) 2015 and the doctor performed an upper endoscopy which confirmed the leads had penetrated the stomach wall.The doctor replaced both leads at that time.It was noted that the patient had a very thin stomach wall and she suffered from long term severe anorexia.At the time of this report, the patient was doing fine and there was no further information.The patient was indicated for gastrointestinal/ pelvic floor.No further information was provided about this event.If additional information is received, a follow up report will be sent.

• 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; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5360232
• MDR Text Key: 35662785
• Report Number: 3007566237-2016-00199
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/31/2015

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: 02/06/2017
• Device Model Number: 4351-35
• Device Catalogue Number: 4351-35
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2015
• Initial Date FDA Received: 01/12/2016
• Date Device Manufactured: 02/06/2015
• 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): Other; Required Intervention