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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE Back to Search Results
Model Number 353101
Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Electro-Static Discharge (2149); Environmental Compatibility Problem (2929)
Patient Problems Device Overstimulation of Tissue (1991); Insufficient Information (4580)
Event Date 03/24/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from an advanced evaluation trial patient who was using an external neurostimulator (ens), via a manufacturing representative.The patient reported that they experienced intense stimulation while voiding.When they checked the enhance verify in my therapy it said the therapy was ¿off.¿ it was unclear if the amplitude somehow increased and shut off by itself.The rep noted that it was unclear if an environmental circumstance could have lead to this as it seemed like it was a technical issue.The patient turned their therapy back on after noticing that it was shut off.They started up at a lower amplitude and it was fine.They came in later that day for their stage 2 procedure.The issue was resolved at the time of the report.
 
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 a patient and healthcare professional (hcp) via a manufacturer representative (rep).The rep reported that the cause of the intense stimulation and device turning itself off was not determined.The patient seemed to think it was an environmental factor that caused it.The way the physician interpreted what happened was that it was like something caused the stimulation to zip all the way up to the max and then shut itself off.After the patient felt the intense stimulation which was only felt for a few seconds, they checked their remote and it said therapy was off.
 
Event Description
Additional information was received from a manufacturer representative (rep).The rep reported that the patient was unsure of the environmental force.She had initially thought maybe the weather as there was a storm.
 
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.
 
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Brand Name
VERIFY ENHANCED
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
MDR Report Key11575221
MDR Text Key243578697
Report Number2182207-2021-00531
Device Sequence Number1
Product Code EZW
Combination Product (y/n)N
PMA/PMN Number
P970004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup
Report Date 05/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number353101
Device Catalogue Number353101
Was Device Available for Evaluation? No
Date Manufacturer Received04/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age60 YR
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