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

Model Number 37800

Device Problems Display or Visual Feedback Problem (1184); Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2020, product type: lead, product id: 435135, serial#: (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 21-jan-2013, udi#: (b)(4); product id: 435135, serial/lot #: (b)(4), ubd: 21-jan-2013, udi#: (b)(4).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 (rep) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that there was a ¿check ins clock¿ on the clinician programmer.The patient was in severe pain and they were doing well 7-10 days prior to the report.It was noted that it looked like a possible lead sticking up on the esophagogastroduodenoscopy (egd), but it was submucosal.Additional information was received from the hcp via the rep.It was reviewed that the ins and clinician programmer were off by one hour.Additional information was received from the manufacturer representative (rep).The patient¿s identifying information was provided.It was reported that they were not sure what the cause of the ¿check ins clock¿ message was even after confirming with the healthcare professional (hcp).The rep instructed the hcp how to correct the time in the ins but they did not have confirmation that this was done.An egd was performed and there was evidence of lead migration in the stomach.They did not know what caused it.The patient was referred to a different hcp who replaced both leads and ins on (b)6) 2020.The patient was doing much better.No further patient complications were reported as a result of this event.

Manufacturer Narrative

Continuation of d11: product id: 435135; lot#serial#: (b)(6); implanted: on (b)(6); explanted: on (b)(6) 2020; product type: lead; product id: 435135; lot#serial#: (b)(6); implanted: on (b)(6) 2011; explanted: on (b)(6) 2020; 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.

• 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
• MDR Report Key: 9857403
• MDR Text Key: 184201961
• Report Number: 3004209178-2020-05745
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

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: 12/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention