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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 Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Battery Problem (2885); Insufficient Information (3190)
Patient Problems Nausea (1970); Vomiting (2144); Malaise (2359)
Event Date 08/26/2021
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 patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation and gast rointestinal/ pelvic floor.It was reported that they stated they turned off patient's ins while in the hospital.The patient reported when in the hospital, the patient had a bunch of tests completed and stated they had an mri scan.The patient stated they went to the er first and stated this all started on (b)(6).Pt stated they didn't know their ins was turned off while pt was in the hospital until two days later and stated they saw the healthcare provider (hcp) that informed pt that their ins was turned off and stated hcp "reset it".Pt stated at that time they were told their ins battery is low and stated the soonest they can get in for surgery is (b)(6) due to no rep availability prior to them.Pt reported they contacted the hcp yesterday and stated they think ins needs to be "tweaked" or turned up or ins battery is already dead because pt can tell ins is not working.Pt stated it's either dead or barely working.Pt stated they don't know what condition they will be in or if they will be alive if pt needs to wait for (b)(6).Pt stated they need this done tomorrow because pt is already sick, nauseous, throwing up.Patient stated they have hcp appt.Today at 1:30 pm to "see if something happened to it again".Agent did not ask about the circumstances that led to the reported issue.The patient was redirected to their healthcare provider to further address the issue.
 
Event Description
Additional information was received from the patient.The patient stated that during an emergency room trip, the device was turned off while having a mri.The issue was not due to normal battery depletion.The patient went to see the healthcare provider (hcp) and the hcp was able to turn the device back on.Device removal is planned for (b)(6) 2021.No further complications were reported.
 
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.
 
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.The patient stated that during an emergency room trip, the device was turned off while having a mri.The issue was not due to normal battery depletion.The patient went to see the healthcare provider (hcp) and the hcp was able to turn the device back on.Device removal is planned for (b)(6) 2021.No further complications were reported.
 
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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
MDR Report Key12469374
MDR Text Key271332108
Report Number3004209178-2021-13812
Device Sequence Number1
Product Code LNQ
UDI-Device Identifier00643169360686
UDI-Public00643169360686
Combination Product (y/n)N
PMA/PMN Number
H990014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/28/2016
Device Model Number37800
Device Catalogue Number37800
Was Device Available for Evaluation? No
Date Manufacturer Received10/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
Patient Weight81
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