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

Model Number 3116

Device Problems Electromagnetic Interference (1194); Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330); Electric Shock (2554); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 06/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient had a gradual loss of therapy.Their nausea was getting worse for about a year, but recently it had gotten worse.The patient was referred to their hcp to determine if further stimulation adjustment was necessary, but the hcp didn¿t want to change any settings.The patient was also getting a shocking sensation.This was initially near the neurostimulator, but later it was within three inches of the neurostimulator.The shocking sensation came gradually from the top of the stomach and then to the bottom of the stomach.The patient noted it was severe contraction.The sensation was not as apparent on the day of the report.It was noted that there were no identifiable issues with impedance that would have caused the shocking sensation.The impedance result on the day of the report showed: 0c at 4,000 ohms, 1c at 4,000 [ohms], 2c at 499 [ohms], 3c at 446 [ohms], 0-1 at 4,000 [ohms], and 2-3 at 499 [ohms].It was noted that the battery was okay based on the system check and the impedance was appropriate for the therapy.The patient was going to follow-up with the hcp.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp).It was reported that the patient was still having an on/off intermittent shocking sensation.The patient recently went to the hcp to check the device and it was working normally.The patient told the hcp that the sensation was like a vibrating sensation.

Event Description

Additional information was received from the patient.They called about getting the battery replaced due to normal depletion.They re-stated that their implant has been shocking them, and they have to keep turning it down.They noted that this had been going on for a couple years, maybe the middle of 2019.They said that they had taken some falls, but every time they took an image and said it looked fine.

Manufacturer Narrative

B3.Date is estimated; year is valid.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 a healthcare professional (hcp).The hcp reported that the cause of the replacement was normal depletion.Device removal or replacement was planned, but the date of surgery was 'tbd.' the issue was not yet resolved, and the device was still in use.

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 were getting weird feelings she gets weird twitches in stomach realized getting shocked.Didn't have the experience until they had stimulator too high.Patient said the stimulator floats in her abdomen.The doctor said if you don't want it replaced why not leave the system in.She said her weight fluctuates and the system hurts.Patient is thinking about having the system removed, and not having it put back in because doesn't want to risk things.Stimulator is technically supposed to be dead.When go through metal detectors at walmart or north 40 she is setting them off.They said stimulator is dead but apparently it isn't dead.Wants to decide if get stimulator replaced does security mess with it.I asked her what she means by setting it off.She said, the theft detector alarms.

• 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: 9612612
• MDR Text Key: 176831823
• Report Number: 3004209178-2020-01473
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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: Consumer,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/05/2022

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: 12/28/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 02/11/2020; 05/14/2021; 06/11/2021; 07/01/2022
• Supplement Dates FDA Received: 03/04/2020; 05/27/2021; 07/01/2021; 07/05/2022
• Date Device Manufactured: 07/08/2014
• 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
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 79 KG