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

Model Number 3116

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)

Patient Problems Pain (1994); Electric Shock (2554); Insufficient Information (4580)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

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 and gastrointestinal/pelvic floor therapy.It was reported that they have been having a lot of issues with their pacer.The pain is out of control.The patient said they were having sharp shocking pain near the pacer.They said their healthcare professional thinks something is wrong.The patient was attempting to locate a healthcare professional and was told by their clinic they cold be seen january 18th.A list of physicians was sent to the patient.The patients relevant medical history included being diagnosed with epiploic appendagitis.

Manufacturer Narrative

B3: date is approximate.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.Reported they have been having serious issues with device for a couple months.The patient clarified they have been having severe sharp pain where ins is.The patient stated they have not been able to get into hcp's office and stated next available appointment that the patient has scheduled is for january 18th.The patient reported due to this they were admitted to the emergency room on new year's eve and the patient is still hospitalized now.The patient stated they still haven't been seen by gastro and was told the only way the patient could have ins interrogated is through outpatient.The patient stated they had a cat scan that showed ins is in place, but the patient stated they know something is wrong.The patient stated they haven't had device interrogated in a long time and stated they are wondering if battery may be dead.The patient stated this all started approximately (b)(6) 2020.The patient stated that there are sending back home in the same conditions he was admitted.The patient was redirected to their healthcare provider to further address the issue.

Manufacturer Narrative

A2 correction: 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.

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 they went to see the healthcare professional (hcp) who checked patient's device and said that it needs to be replaced.The patient reported that their ins hasn't been working for over a year, and they saw the hcp who told them that they would replace the ins because the battery is "almost dead" and needs to be replaced.That patient stated that their "symptoms have tippled." they stated they have to suffer while they wait for replacement.That said that if they can't get ins replaced "i'll throw up every day and maybe i'll die." they called in again stating that they had identified an hcp to perform the replacement surgery, but they were having difficulties with insurance coverage.The patient was very upset stating if they cannot get this replaced, they will be throwing up all the time and it is not fair.

Event Description

Additional information was received from the patient.They reported that they want to know the status of where they are on replacing the implant because they said they find the stimulator's ineffective, patient further reported that they had an unrelated surgery and since then surgery they have increase problem with the battery no further complications were reported/anticipated 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.

• 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: 11018797
• MDR Text Key: 221762749
• Report Number: 3004209178-2020-21968
• 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,Followup,Followup,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2013
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/04/2021; 02/01/2021; 04/21/2021; 05/12/2021
• Supplement Dates FDA Received: 01/06/2021; 02/01/2021; 05/06/2021; 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR