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

Model Number 3116

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330); Weight Changes (2607)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37800, serial#: (b)(4), implanted: (b)(6) 2019, product type: implantable neurostimulator.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2008, product type: lead.Product id: 435135, serial#: (b)(4), implanted:(b)(6) 2008, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 26-mar-2010, udi#: (b)(4), product id: 435135, serial/lot #: (b)(4), ubd: 25-mar-2010, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator (ins) for gastric stimulation.It was reported that the patient started having visible stomach contractions and their symptoms returned towards the end of their first inss life.The device was replaced and they thought this would fix the issues, but it didn't.Their symptoms were worse shortly after implant than they previously were.The patient was experiencing uncomfortable and painful muscle contractions on the left side of their abdomen.They noted they contracted in a rhythmical pattern.The patient saw a correlation with this once they had eaten something and had food in their stomach.The patient took a video of this and showed it to a manufacturing representative (rep).The rep turned the intensity down and stated they believed the issue could be related to electrode erosion since the lead was not replaced during the ins replacement.The patient stated the decreased intensity did not help with the issue.The patient believed these issues were related to the lead not being replaced at their most recent replacement surgery and the issue persisted.The patient further mentioned being on an iv and losing weight and having a lot of boney protrusions.They did not provide any additional information regarding this.No further complications were reported or anticipated.

Event Description

Additional information was received from the patient.They provided their weight at the time of the event.They stated the electrode erosion was only suggested as a possible cause for the abdominal contractions by a manufacturer representative (rep).They stated it has become clear the contractions only occur following a moderate food/fluid consumption.The frequency of the contractions has greatly decreased by eating or drinking smaller amounts throughout the day.The patient has contacted the rep to readjust settings and will have their surgeon investigate possible lead dysfunction as soon as possible.The issue has not been fully resolved at the time of the report due to health care restrictions and the patient¿s personal health status.No further patient complications were reported as a result of this event.

Manufacturer Narrative

Continuation of d11: product id 37800 lot# serial# (b)(6) implanted: (b)(6) explanted: product type implantable neurostim ulator product id 435135 lot# serial# (b)(6) implanted: (b)(6) explanted: product type lead product id 435135 lot# serial# (b)(6) implanted: (b)(6) explanted: product type lead medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 00777
• MDR Report Key: 10043246
• MDR Text Key: 190553161
• Report Number: 3004209178-2020-08382
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2011
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 45