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

Model Number 37800

Device Problems Malposition of Device (2616); Battery Problem (2885); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, lot#/ serial#: (b)(4), product type : lead ; product id: 435135, lot# / serial#: (b)(4), product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 09-nov-2012, udi#: (b)(4) ; product id: 435135, serial/lot #: (b)(4), ubd: 02-feb-2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported that the caller indicated that the healthcare provider (hcp) replaced the lead at a procedure in the past and they left the ins implanted.The caller did not have any other details about that case at the time of the call.Troubleshooting was not required.The issue was not resolved through troubleshooting.Additional information was received from the manufacturer representative (rep).The rep stated that the leads were replaced on (b)(6) 2021 due to impedance concerns that the healthcare provider (hcp) thought might have been due to poor placement of the original leads.It was also reported that during a device check follow-up appointment, the technician was concerned because a "check ins clock" message was displayed on the clinician programmer.They thought the message was due to the patient's device resetting when the leads were replaced and that this was likely done accidentally with the programmer during the process and does not affect performance of the device or delivery of therapy.The ins is working properly.No further complications were reported.

Event Description

Additional information was received from the manufacturer representative (rep).The rep stated that the leads were replaced on (b)(6) 2021 due to impedance concerns that the healthcare provider (hcp) thought might have been due to poor placement of the original leads.It was also reported that during a device check follow-up appointment, the technician was concerned because a "check ins clock" message was displayed on the clinician programmer.They thought the message was due to the patient's device resetting when the leads were replaced and that this was likely done accidentally with the programmer during the process and does not affect performance of the device or delivery of therapy.The ins is working properly.No further complications were reported.Additional information was received from the manufacturer representative (rep).The rep stated that the message of check ins meant a accidental reset of the neurostimulator.No further complications were reported.

Manufacturer Narrative

Concomitant medical product: product id 435135 lot# serial#(b)(6) implanted: explanted: product type lead product id 435135 lot# se rial# (b)(6) implanted: explanted: 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: 12489049
• MDR Text Key: 271934170
• Report Number: 3004209178-2021-14039
• 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
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR