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

Model Number 37800

Device Problems Migration or Expulsion of Device (1395); Battery Problem (2885); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Erythema (1840); Internal Organ Perforation (1987); Pocket Erosion (2013); Obstruction/Occlusion (2422); Abdominal Distention (2601); Swelling/ Edema (4577); Insufficient Information (4580)

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 who was implanted with an implantable neurostimulator (ins) for unknown gastric indications for use.It was reported that the patient said they had a problem (no other information was given).While transferring the call, the patient disconnected.Later that day, the patient reported they had, "trauma 1, trauma 2, trauma 3 and now trauma 4." it was not clear what they were referring to by this and the patient was challenging to follow.The device had fallen out of the pocket.The batteries were depleted.A computed tomography scan (ct) scan showed it was blocking the abdominal wall, the intestines were swollen, and showed all three devices, wires, and tissue adhesions everywhere.Their stomach had a small hole leaking gastric fluids on top of their intestines and that was why the intestines were swollen.The device was broken; it fell off and was not working.They noted they were a victim of domestic violence and had diabetes and gastroparesis and vomited every day and feared they would die (no allegation related to device/therapy).They had been working with a doctor who canceled the patient's surgery because they wanted the patient to do another stomach emptying test which the patient did not want to do.They asked for physician listings to find a doctor to remove the devices.Six days later, the patient called back and repeated a lot of the same information.They were looking for a surgeon to help fix their situation.Their third implant was done by a doctor who did the surgery the same day and sent them home with the possibility of having a blood clot.The patient stated this doctor was committing malpractice and negligence.Their vitals were all crazy and their abdomen was very swollen, as the device was coming out of their pocket and the incision was red.Two ct scans with iodine confirmed this.They stated it was a miracle they were alive, but they were disabled and were bedridden due to fractures in their back (no allegation related to device/therapy).They later stated they were dying (no allegation related to device/therapy), and that they had diabetes and gastroparesis which are fatal conditions.The role of the manufacturer versus the doctor was reviewed and physician listings were provided again to the patient.

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 spoke with hcp christopher bell that is willing to remove all three enterra ii gastric stimulators that pt stated they still have implanted.Pt stated the "third one is in my bicep" (agent not clear what pt was referring to by this statement).Pt stated they also have "a bunch of cables" and stated dr.Bell is willing to take out all of the devices and cables but stated dr.Bell won't implant another enterra device.Pt stated that gastroparesis is a fatal disease and pt stated they will die without another device.Pt stated the vomit every time they eat the food comes right back up.Pt then stated they will "die anyways".Pt stated their life is in danger and stated if they die they are coming for their drs in court in a coffin.Pt stated they have talked to all drs on the physician listing pt received and dr.Bell is the only dr that will remove the devices.Redirected pt to insurance/pcp for more hcp information.Reviewed role of ps and redirected pt to hcp to discuss medical concerns.Pt then disconnected call so agent was unable to collect any further event information.On (b)(6) 2021, the patient called back and reported dr.Bell is willing to remove the devices but would maybe consider implanting a new enterra in 6 months to a year.Patient was told they only have 4 months to live.Reviewed role of medtronic and patient became escalated and hung up.

Manufacturer Narrative

Continuation of d10: product id 4351-35; serial# (b)(6); product type: lead; product id: 4351-35; serial# (b)(6); 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.

Event Description

Additional information was received from the patient.They reported that they received a letter however unable to get patient to review.Patient saw that she did see hcp who told her that he would remove the 3 enterra systems patient has in her body however would not implant a new one.Patient said that she heard him talking to someone and believes that he said that he wants to save her life however only removes and hasn't ever implanted the enterra system.Patient said that when she heard that she left the facility right away.Patient said needs a new system after the other ones are removed.Reviewed listings with patient over the phone and redirected patient to continue searching for surgeon to assist in her situation.On an additional call the patient reported the cables from the 3rd device are trying to eject from their stomach and they look like they are seven months pregnant.

• 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: 12443809
• MDR Text Key: 270568192
• Report Number: 3004209178-2021-13535
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2021

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: 08/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 09/21/2021; 11/17/2021
• Supplement Dates FDA Received: 10/20/2021; 12/13/2021
• Date Device Manufactured: 03/01/2017
• 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...."
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female