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 Erosion (1750); Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987)

Event Date 04/15/2022

Event Type  Injury  

Event Description

Information was received from a patient via manufacturer representative, regarding the patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.The patient reported that  device is eroding and they are bleeding.They are at hosp ital inpatient and stated that the physicians will not treat them.The patient was given local implant centers in their vicinity by the rep for the hospital to contact.A nurse may call the rep.The issue was not resolved at the time of the report.Surgical intervention did not occur and it was unknown if surgical intervention was planned.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider via a manufacturer representative (rep).The rep reported that the patient was sent to another medical center by the doctor who had admitted them, to meet with an implanting physician.Two days later, they reported the patient was admitted by their local hospital due to concerns their implanted device was starting to erode through the skin.The issue was first noticed (b)(6) 2022.When asked to clarify which components the patient was experiencing erosion with, they stated one lead was involved in the issue, but the physician could not identify the serial number on the lead causing the issue.They again confirmed the component involved in the complaint was a lead.The location of the "eroding and bleeding" was "gastric antrum near lead implant site." the device was fully explanted, leads and battery, on (b)(6) 2022.The issue was resolved.It was noted the information was provided to the rep by the implanting physician the patient had been sent to, and who explanted the patient's device.

Manufacturer Narrative

Continuation of d10: product type lead product id 4351-35 lot# serial# unknown implanted: (b)(6) 2018 explanted: (b)(6) 2022 product type lead note: lead serial # was either: (b)(6) or (b)(6) (both 4351-35 model numbers), but it was unknown which was involved in the erosion and bleeding event.The ins and both leads were explanted.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
• 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: 14349484
• MDR Text Key: 291328886
• Report Number: 3004209178-2022-06003
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2022
• Date Device Manufactured: 03/27/2018
• 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...."; SEE H10
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 34 YR
• Patient Sex: Female