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

Model Number 3116

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

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351, lot#: unknown, product type: lead.Product id: 4351, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implanted neurostimulator (ins) for gastric stimulation.It was reported that the patient is upset they had three or four surgeries in 2017 and they didn't replace the stimulator.The stimulator is now dead due to normal battery depletion.Asked if the three or four surgeries were related to an issue with the device or therapy.The patient said yes the lead had burned off.Asked what they meant by burned off.The patient said something was wrong with the lead and they had to replace it.The acidity was so high it did something to the lead and ate at her throat.They cut open her stomach and made a bigger hole for emptying.It actually helped and she felt a lot better; she could eat whatever she wanted.She said her stomach is so slow it is at 17% when working by itself.Goes to the bathroom once a month.Asked when the patient had the issue with the lead and she said she had it replaced on (b)(6) 2017.Agent did not ask about the circumstances that led to the reported issue.Patient said in 2001, they were (b)(6) pounds and almost died of malnutrition but is thankful for manufacturer because it did help.

Manufacturer Narrative

Continuation of d10: product id 4351, lot# unknown, product type lead.Correction: b5 and h1 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

Information was received from a patient with an implanted neurostimulator (ins) for gastric stimulation.It was reported that the stimulator is now dead due to normal battery depletion.Asked if the three or four surgeries were related to an issue with the device or therapy.The patient said yes the lead had burned off.Asked what they meant by burned off.The patient said something was wrong with the lead and they had to replace it.She said her stomach is so slow it is at 17% when working by itself.Goes to the bathroom once a month.Asked when the patient had the issue with the lead and she said she had it replaced on (b)(6) 2017.Agent did not ask about the circumstances that led to the reported issue.

• 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: 10824345
• MDR Text Key: 215905896
• Report Number: 3004209178-2020-19775
• 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: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 46 YR