MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEU_ENTERRA_INS; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 4351-35, product type lead.

Event Description

Omitted information regarding the additional patient¿s erosion, see pe (b)(4) the patient¿s healthcare provider reported via manufacture representative that the patient experienced a lead erosion into the stomach.It was unknown if any environmental/external/patient factors that may have led or contributed to the issue.There were no further complications reported and/or anticipated.

• Brand Name: NEU_ENTERRA_INS
• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6926741
• MDR Text Key: 88934331
• Report Number: 3007566237-2017-04244
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: NEU_ENTERRA_INS
• Device Catalogue Number: NEU_ENTERRA_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/07/2017
• 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