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

Model Number 37800

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146); Fibrosis (3167)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2021, product type: lead.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 09-feb-2008, udi#: (b)(4); product id: 435135, serial/lot #: (b)(4), ubd: 09-feb-2008, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the patient complained of pain and burning in the clinic.Surgery was scheduled to explore the pocket.Fibrotic tissue was discovered due to lead wire contact with tissue.It was believed that the lead coating may have been missing and caused the issue.It was noted there was no infection.Impedance checks and parameter changes had been performed.It was noted that the leads had been cut from the stimulator and partially explanted.It was reported the issue was resolved at the time of the report.

Manufacturer Narrative

H3: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing.The leads (b)(6) and (b)(6) were returned segmented; however electrical testing of the returned segment(s) determined that continuity was complete and there were no electrical shorts between the circuits.Continuation of d10: product id: 435135, serial# :(b)(6), implanted: 2006 (b)(6), explanted: 2021 (b)(6), 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11744182
• MDR Text Key: 247909498
• Report Number: 3004209178-2021-06886
• 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: 09/21/2021

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: 01/28/2021
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 09/20/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR