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

Model Number 3116

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 435135, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.Product id 435135, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

A healthcare provider (hcp) reported that a patient's gastric pacemaker and fractured lead were removed due to an infected site.No further complications were reported/anticipated.

Manufacturer Narrative

Evaluation code applies to the leads and applies to the ins.Product analysis #(b)(4): product id# 3116: the implantable neurostimulator (ins) passed functional testing and there were ins ignificant anomalies.Leads, product id#435135: the lead was returned segmented; however electrical testing of the returned segment(s) determined that continuity was complete and there were no electrical shorts between the circuits.During visual analysis of the lead, it was noted the distal end was not returned.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the cause of the infection and fractured leads was a self-inflicted stab wound to the abdomen along [illegible] gastric stimulator lead.It was noted the infection had been resolved.No further complications were reported/anticipated.

• 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 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6522745
• MDR Text Key: 73730902
• Report Number: 3004209178-2017-09101
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2018

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: 11/14/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 04/26/2017
• Supplement Dates Manufacturer Received: Not provided; 06/02/2017; 01/30/2018
• Supplement Dates FDA Received: 06/21/2017; 10/03/2017; 02/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2011
• 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): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 73