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

Model Number 37800

Device Problems Premature Discharge of Battery (1057); Break (1069); High impedance (1291); Energy Output Problem (1431); Battery Problem (2885); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Pyrosis/Heartburn (1883); Nausea (1970); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Malaise (2359); Insufficient Information (4580)

Event Date 11/24/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 435135, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.Product id 435135, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.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

A manufacturing representative (rep) reported on behalf of a healthcare provider (hcp) that a patient had a lead #2 that was out of range and measuring 2081 ohms.Lead #3 was in normal range of 390ohms.The rep informed the hcp to change the polarity on the leads until which time the surgeon can do a lead revision.The patient further reported they had been sick for 10days.They went to their hcp office and they determined that their impedances were too high, "itwas like 800".The hcp said it could be the wire was broken or malfunctioning, or it could be the scar tissue causing it.They said if the lead was broken then the impedances would be zero.The patient mentioned their ins was 20 months old and their last ins lasted for 19 months.They did not want to go for 2 procedures and would rather wait for the ins to die.The confirmed that the previous ins died due to normal battery depletion.The patient stated that their leads were not replaced and they were 5.5 years old.Symptoms were noted to be sudden.Additional information from the hcp noted that the issue, per the surgeon, was "scar tissue".The patient was first seen on (b)(6) 2016 and impedance was greater than 800 indication a malfunction of the lead #2.The hcp recommended a second stimulation check prior to surgical intervention.The patient was seen in the hcp on (b)(6) 2016 and they noted that they interrogated the patient's gastric stimulator.The patient stated they still did not feel that they were 100% at the time of that check up.They had some nausea on a daily basis, but had not vomited.The patient also has occasional heartburn and abdominal pain.They were eating a very bland diet.The assessment and plan noted the stimulator was checked and revealed an impedance of 657 (normal range 2 - 800).Their stimulation was set to overdrive #4.They refilled a prescription medication.The following medications were listed as the patient's outpatient prescriptions: aczone 5% top gel, bifidobacterium infantis 4 mg daily, esomeprazole 40mg oral delayed release capsule 1 daily, folic acid 1 mg oral tablet, metoclopramide 10mg oral tablet 3x daily, mirtazapine 15mg oral tablet 7.5 mg by mouth at bedtime, norethindrone 0.35mg oral tablet, ondansetron hci 8 mg oral tablet by mouth every 12 hours, polyethylene glycol 3350 take by mouth as needed, tretinoin 0.01% topical gel applied to affected area at night, errin 0.35mg oral tablet take 1 tablet my mouth daily.The patient is to follow up with the hcp on (b)(6) 2017.The ins indication for use was gastric stimulation.

Manufacturer Narrative

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 from the patient noted they were rechecked by their gastrointestinal (gi) doctor and their levels were then within normal limits.

Event Description

The patient reported that their device was replaced.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.They reported the reason for the call was to report their battery drained more quickly than usual (in 19 months), because their wires had been broken.They reported the health care provider (hcp) could not pinpoint the exact reason for the wires breaking, and stated they thought it was because of "wear and tear." the patient stated they did not do extreme sports but they were a physical therapist and so they did move and turn because of this profession.The patient stated they also would occasionally golf.They also reported it was odd that when the hcp had done the impedance reading at the time the impedance was within range.The patient stated they believed the impedance had been "471 or 474".The system was replaced on 2017-apr-05.

Manufacturer Narrative

Concomitant medical product: product id 435135 serial# (b)(6) implanted: (b)(6) 2011 explanted: (b)(6) 2017 product type lead product id 435135 serial# (b)(6) implanted: (b)(6) 2011- explanted: (b)(6) 2017 product type lead h6: due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been 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.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 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: 6225458
• MDR Text Key: 63959771
• Report Number: 3004209178-2017-00276
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2022
• Date Device Manufactured: 03/05/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female