MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Adhesion(s) (1695); Device Embedded In Tissue or Plaque (3165)

Event Date 03/22/2016

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.

Event Description

The health care provider (hcp) via a manufacturer representative reported that the patient underwent surgery for lead and battery re placement on (b)(6) 2016.The patient's previous pair of gastric leads were not removed as the patient had extensive adhesions.The indication for use for this patient was gastric stimulation.

Manufacturer Narrative

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5666777
• MDR Text Key: 45517964
• Report Number: 3004209178-2016-09859
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

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: 05/28/2016
• 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: 04/27/2016
• Initial Date FDA Received: 05/19/2016
• Supplement Dates Manufacturer Received: 04/27/2016
• Supplement Dates FDA Received: 09/22/2017
• Date Device Manufactured: 12/13/2014
• 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 Age: 56 YR