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

Model Number 37800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Complaint, Ill-Defined (2331); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2020, product type: lead.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 30-sep-2013, udi#: (b)(4).Product id: 435135, serial/lot #: (b)(4), ubd: 30-sep-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 an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported that the patient had an infection in the site of the battery pocket from the battery replacement surgery.The hcp took the patient to the operating room to remove the battery.The hcp partially removed the leads stating they couldn't remove them fully due to patient complications.

Manufacturer Narrative

Continuation of d10: product id 435135 serial# (b)(6) implanted: (b)(6) 2012 explanted: (b)(6) 2020 product type lead product id 435135 serial# (b)(6) implanted: (b)(6) 2012 explanted: (b)(6) 2020.Product type lead h6: due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.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.

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer representative (rep).It was reported that the physician removed the battery and was planning to do a full removal of leads.They later reported that the physician removed all leads and battery, and had no additional information at this time.

• 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: 10764337
• MDR Text Key: 214171649
• Report Number: 3004209178-2020-19036
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00763000286798
• UDI-Public: 00763000286798
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR