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

Model Number 37800

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2022

Event Type  Injury  

Manufacturer Narrative

See manufacturer¿s report 3004209178-2023-00033 for concomitant ins information 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 an unknown source regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that dr.  saw the patient in the office and the device was off.A screen appeared stating to reset the ins clock.He turned the battery back on but it recommended to change the battery soon as it was low.This patient is on high settings 10v, rate of 110, 3 sec on 2 sec off.Batteries are only lasting 4-5 months.And there was an early battery depletion they plans on sending this battery back for analysis.Additional information was received from the manufacturer representative (rep).They stated that battery was replaced on (b)(6) 2023.Program settings were 10 volts, 110 rate.Replaced battery again on (b)(6) 2023.Patient was on very high settings.Dr.Did egd to confirm leads had not eroded.All looked good.Lowered to 7.5 volts and 28 rate on off time was 1/4.Also, changed polarity on the leads.The physician's assistant was not sure what happened to the product.

Manufacturer Narrative

Continuation of d10: product id 37800 serial# (b)(6) implanted: (b)(6) 2022 explanted: (b)(6) 2023 product type implantable neurostimulator.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 the patient's healthcare provider (hcp).It was reported that the second device was exhausted and needed to be replaced.Egd was done at the time of replacement and no lead revision was observed.The cause of the second battery replacement was determined to be due to the patient had been on very high settings, which is why it exhausted early.However, the patient has improvement in symptoms and is better functioning with high settings.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16807673
• MDR Text Key: 313927017
• Report Number: 3004209178-2023-05518
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00763000449704
• UDI-Public: 00763000449704
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Date Device Manufactured: 10/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 62 KG