MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA THERAPY; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problems High impedance (1291); Device Operates Differently Than Expected (2913)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 435135, implanted: (b)(6) 2013, explanted: (b)(6) 2013, product type: lead.If information is provided in the future, a supplemental report will be issued.[mw5073403.Pdf].

Event Description

The healthcare provider (hcp) reported via the user facility that there was high impedance and a lead malfunction.A revision occurred and the device was explanted on (b)(6) 2013 due to lead erosion.The patient outcome was hospitalization.There were no further complications reported as a result of this event.The device was implanted for was gastroparesis.

Manufacturer Narrative

Product id: 435135, serial# unknown, implanted: (b)(6) 2013, explanted: (b)(6) 2013, product type: lead.Life threatening was removed as it was incorrectly applied to this event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENTERRA THERAPY
• 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: 7156295
• MDR Text Key: 96110207
• Report Number: 3007566237-2017-05342
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 06/14/2018
• 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): Hospitalization; Life Threatening; Required Intervention