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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR Back to Search Results
Model Number 37800
Device Problems High impedance (1291); Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927); Environmental Compatibility Problem (2929); Impedance Problem (2950)
Patient Problems Nausea (1970); Insufficient Information (4580)
Event Date 04/07/2021
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 healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor.It was reported that the patient's impedances were showing higher the day of the report, with: c2 = 521, c3=328 and 23 = 944 ohms.The patient did have a cholecystectomy (not alleged to be related to device/therapy) on (b)(6) 2021, and felt like they were having worsening nausea since then.They were doing fine before the surgery, but were still relying on tube feeding to help them manage their symptoms.When asked if this was similar to the patient's baseline symptoms, the caller was not able to answer due to the patient having a difficult case.No reprogramming had occurred since the surgery and the patient's stimulation was showing on the day of the report.Before further troubleshooting could be done, the caller received a call back from a manufacturer representative the caller had left a message with, so the caller disconnected.
 
Manufacturer Narrative
H6: device code a19 no longer applies to this file.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.
 
Event Description
Additional information was received from a health care professional (hcp) via a manufacturer representative (rep).The reported that the patient¿s symptoms had returned and that the environmental/external/patient factors that might have contributed to the issue were that the patient had gall bladder removal shortly (a few months) after implant (gastric stimulator placement) and the device had possibly not been turned off.The rep also noted that the patient had a breast reduction surgery in spring of 2021 (not alleged to be related to the device/therapy.) the rep called during the replacement (on (b)(6) 2020) and stated that they were in the operating room (or) and prior to the surgery, impedances were checked and out of range on c-2 and 2-3.The caller stated the health care professional (hcp) replaced the ins battery and the first time impedances were checked, 2-3 was out and c-2 was ¿more in range.¿ impedances were then checked again and 2 of the pairs normalized but the other pair was out of range.The rep stated that they were testing impedances at default values and that the ins had been sitting outside the pocket on the patient¿s skin.The caller stated there were no issues inserting the leads into the ins and that they'd already cleaned the leads twice.The caller stated that the most recent results showed c-2 / c-3 were greater than 20k ohms, c-3 was 528 ohms and 2-3 was 509 ohms.Technical services reviewed that while impedances were on the lower side, these were normal and it would be up to the health care professional (hcp) if these were acceptable or not but that the only other option would be to replace the leads.The troubleshooting steps that were taken on the call resolved the issue.Technical services sent an email to the caller for more information since they had been in the middle of the case.The rep reported that ¿yes,¿ the issue was resolved at the time of the report, they also indicated that the event date that the impedances were first noticed or what date if possible did the patient start having therapy issues was ¿unknown.¿.
 
Manufacturer Narrative
H3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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
H3: the implantable neurostimulator (ins) passed functional testing.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.
 
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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 Key11890741
MDR Text Key262480829
Report Number3004209178-2021-08413
Device Sequence Number1
Product Code LNQ
UDI-Device Identifier00763000286798
UDI-Public00763000286798
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H990014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup,Followup
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2022
Device Model Number37800
Device Catalogue Number37800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2021
Date Device Manufactured09/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age46 YR
Patient SexFemale
Patient Weight98 KG
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