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

Model Number 37800

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Hemorrhage/Bleeding (1888)

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 batteries were depleted and a computed tomography (ct) scan showed all three devices, and tissue adhesions everywhere.The patient asked for physician listings to find a doctor to remove the devices.The patient stated their second implant is somewhere in their body.Additional information was received from a healthcare provider (hcp).When asked to clarify the statement the ct scan showed all three devices and whether or not the patient's second ins was left implanted, the healthcare provider responded that ins was not left implanted.They noted the generator replacement was the only procedure performed by them.When asked what steps were or would be taken to resolve the issue, they stated ct scan reports were not available for review.If obtained, they would review and make adjustments as needed.The issue was not yet resolved.No additional surgery was planned to try to remove the second ins.They provided procedure notes from when this ins was replaced.The patient was presented with a prior gastric pacemaker placement with a nonfunctioning generator, seeking exchange.They had a malfunctioning gastric pacemaker generator.Risks, benefits, and alternatives to surgery were all discussed with the patient and informed consent was obtained prior to the procedure.The patient was presented in the operating room (or) suite in supine position.They were placed on the or bed and induced under general anesthesia.They were intubated.They were prepped in sterile fashion and a timeout was performed to ensure the correct patient and procedure to be performed.Using a 10-blade scalpel, their previous generator incision over their right abdomen was re-incised and the dissection was taken down to the capsule surrounding the generator using electrocautery.The capsule was then incised and the generator removed from the subcutaneous pocket.The leads were then removed from the generator and the new generator placed.Initial impedance was reported as 596 ohms.Upon replacement of the generator back into the subcutaneous pocket, the impedance was 586 ohms.The electrodes were repositioned within the pocket and verified to be firmly attached to the generator.The subcutaneous tissue was then reapproximated using a running 3-0 absorbable suture, the deep dermal layer reapproximated with a 3-0 absorbable suture in a running fashion, and the skin reapproximated using a subcuticular 4-0 absorbable suture in a running fashion.The skin was then dressed with mesh tape.The patient tolerated the procedure well.They were presented to the post-anesthesia care unit in stable condition.There were no intraoperative complications.All counts were correct at the end of the case and the attending was present for all vital aspects of the procedure.This occurred on (b)(6) 2017.There was minimal blood loss.

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 (b)(6) 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.(b)(6) is willing to take out all of the devices and cables but stated dr.(b)(6) 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.(b)(6) 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 2021 (b)(6) the patient called back and reported dr.(b)(6) 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.

• 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: 12368728
• MDR Text Key: 268210618
• Report Number: 3004209178-2021-12933
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention