MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erosion (1750); Internal Organ Perforation (1987)

Event Type  Injury  

Event Description

It was reported that there were 7 patients with electrode erosion into the gastric lumen or abdominal wall, leading to failure of the device.It was stated that the events were treated by device removal, device repositioning, or antibiotic treatment.Additional information was requested.

Manufacturer Narrative

Concomitant medical products: product id 4351, serial# unknown, product type: lead; product id 4351, serial# unknown, product type: lead.(b)(4).

Manufacturer Narrative

Correction: report submitted in error as event was previously reported.

Manufacturer Narrative

Initial report correctly sent as one patient not accounted for erosion into gastric lumen/wall.7 changed to 1 due to 6 reports of erosion that were previously reported.See manufacturing report #'s 6000033-2001-00855, 6000033-2002-00170, 6000033-2002-00691, 2182207-2003-00705, 6000032-2004-00511, and <(>&<)> 2182207-2004-01395.

Event Description

It was reported that a patient had electrode erosion into the gastric lumen or abdominal wall, leading to failure of the device.It was stated that the events were treated by device removal, device repositioning, or antibiotic treatment.Additional information was requested.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 3971696
• MDR Text Key: 4634493
• Report Number: 3007566237-2014-02142
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2014

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 Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 07/31/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/13/2014; 08/18/2014
• 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): Life Threatening; Required Intervention