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

Model Number 37800

Device Problems Disconnection (1171); Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Erosion (1750); Nausea (1970); Hernia (2240); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Weight Changes (2607)

Event Date 02/27/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 4351-35, serial (b)(4), product type: lead.Product id: 4351-35, serial (b)(4), product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

The consumer reported that the patient's implant "failed." there was a problem with it, and they weren't sure what happened to it.The device was not working well/correctly.The patient experienced weight gain, nausea, and a return of gastroparesis symptoms about nine months prior to the report.It was indicated that the settings were increased, and the issue was not resolved.The consumer stated they thought either the leads had grown through the wall of the stomach or had come detached.It was noted when the replacement was done on (b)(6) 2017, they found out the patient had a hernia in the pocket where the stimulator was placed.The leads had grown into the hernia.Further information received from the consumer via a manufacturer representative (rep) indicated that the (b)(6) 2017 was not a replacement.It was reviewed that the consumer should go back to billing if the patient had a revision vs replacement to see if there was a mistake in coding.There were no further complications reported as a result of this event.

Manufacturer Narrative

Removed device code (b)(4) and evaluation code-conclusion for both leads as (b)(4) and more accurately captured this event.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.

• 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: 7109213
• MDR Text Key: 94550004
• Report Number: 3004209178-2017-25847
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2018
• Date Device Manufactured: 08/08/2015
• 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): Life Threatening; Required Intervention
• Patient Age: 10 YR