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

Model Number 37800

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Nausea (1970); Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id 4351-35 lot# serial# (b)(4).Implanted: (b)(6) 2020.Product type lead product id 37800, serial# (b)(4).Implanted: (b)(6) 2020.Product type implantable neurostimulator.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 12-jul-2021, udi#: (b)(4).Product id: 37800, serial/lot #: (b)(4), ubd: 28-aug-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor.It was reported that the patient felt "shocks" lasting up 5 minutes.Upon interrogation, it was discovered that lead 2 was not within an acceptable impedance range.The polarity of the device was changed to turn off that lead until the pocket could be explored.X-ray did not reveal anything abnormal.Patient experienced more nausea with that lead turned off.Patient decided to medicate and postpone implantation of a new lead.No further complications were reported at this time.

Manufacturer Narrative

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.They reported that several attempts had been made to correct the issue by increasing voltage of the remaining lead, noting the last attempt was on (b)(6) 2021.It was unsuccessful and the issue had not yet been resolved.No surgery had been planned/scheduled.

Manufacturer Narrative

Continuation of d10: product id: 4351-35, serial# (b)(6), implanted: (b)(6) 2020, product type : lead; product id: 37800, serial# (b)(6), implanted: (b)(6) 2020, 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 via a manufacturer representative.They reported that the referring and following physician asked that they give the patient a call.When the rep spoke with the patient, they were very upset that the manufacturer had not done anything to help them because the lead and the device were defective.They were reminded of their decision not to intervene surgically and that their options still remained open to a pocket exploration to test the leads with the existing device or new one, and/or lead replacement.The patient was told again that there were other implanters.Their biggest concern was financial, as they did not believe they should have to pay for another surgery.Furthermore, they believed the manufacturer should be financially responsible.It was explained to the patient that was not the case and they were also told the manufacturer had no way to inspect the lead because it was still in their body.They planned to seek resolution with the surgeon.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id: 4351-35; lot#serial#: (b)(6); implanted: on (b)(6) 2020; product type: lead; product id: 4351-35; lot#serial#: (b)(6); implanted: on (b)(6) 2020; product type: lead.Section d and h2: device information corrected.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.

• 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: 11764882
• MDR Text Key: 248796448
• Report Number: 2649622-2021-08825
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169936577
• UDI-Public: 00643169936577
• 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,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 71