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

Model Number 3116

Device Problems High impedance (1291); Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problems Pain (1994); Hernia (2240); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2018, product type: lead.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2018, product type: lead.Information references the main component of the system.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: (b)(6) 2012, udi#: (b)(4).Pertain to product id: 435135, serial#: (b)(4), product type: lead.And product id: 435135, serial#: (b)(4), product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/pelvic floor issues.It was reported that approximately a year ago, the patient started complaining of pain and loss of therapy and the hcp adjusted the patient¿s settings at that time.It was noted that somewhere in the last year, the patient¿s impedance started reading out of range, and on the day of the report, the hcp discovered that the previous surgeon had placed too much of the leads into the pocket, shortening the leads, and pulling the stomach upwards toward the skin.The hcp also discovered one of the leads had pulled away from the stomach and it was causing the impedance issue (c & 3 was greater than 4000).The hcp also discovered a hernia underneath the battery pocket that was causing the patient severe pain; the hernia was repaired and both leads and the battery were removed and replaced with new ones.It was unknown what factors may have led or contributed to the issue.It was noted that the issue was resolved at the time of the report.No further complications were reported/anticipated.

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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7754661
• MDR Text Key: 116208015
• Report Number: 3004209178-2018-17507
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 01/15/2015
• 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