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

Model Number 3116

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2014

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 435135, product type: lead.Product id: 435135, 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 the lead malfunctioned due to twisting of the leads.The device was explanted.This event occurred (b)(6) 2014.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

Information references the main component of the system and other applicable components are: product id 4351-35 lot# serial# (b)(4) implanted: 2013 (b)(6) explanted: product type lead product id 4351-35 lot# serial# (b)(4) implanted: 2013 (b)(6) explanted: product type lead.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7156290
• MDR Text Key: 96110260
• Report Number: 3007566237-2017-05341
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• 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: 02/20/2018

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: 02/14/2015
• 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: 12/05/2017
• Initial Date FDA Received: 12/30/2017
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 02/20/2018
• Date Device Manufactured: 08/21/2013
• 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; Required Intervention
• Patient Age: 44 YR