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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NURO; STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION
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MEDTRONIC NEUROMODULATION NURO; STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION Back to Search Results
Model Number 3533
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dehydration (1807); Swelling (2091); Urinary Retention (2119); Therapeutic Response, Decreased (2271); Malaise (2359); Loss of consciousness (2418)
Event Date 07/30/2019
Event Type  Injury  
Manufacturer Narrative
Date of event is an approximation.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer (con) regarding a patient who was using an external neurostimulator (ens).It was reported that the patient was doing great, but their symptoms returned in the past week.The patient was taken to the hospital as they were unresponsive and feeling ill.They were dehydrated and was unable to urinate, so they had to be catheterized at the hospital.The patient was then brought to see their primary care provider (pcp) to change medications as they believed the medications were affecting the therapy.It was also noted that the patient¿s feet and ankles were severely swollen.They were going to return to the pcp for more medication adjustments to figure out what was affecting the therapy.This issue was not resolved at the time of the report.No device issues or further complications were reported or anticipated.
 
Event Description
Additional information was received from a healthcare professional (hcp).It was reported that the patient had 9 therapy sessions by the time of the event.It was noted that there was a change in blood pressure medicine 1 week prior to the event.A cardiologist was followed up with regarding the cause of the unresponsiveness/feeling ill and actions/interventions taken to resolve the issues.It was noted that the patient had no retention or catheterization in their medical history and the patient had been seen since 2009.No further complications were reported/anticipated.
 
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 received from a healthcare professional (hcp).It was reported that, per the patient¿s daughter, the patient was doing well after a medication change.
 
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
NURO
Type of Device
STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
MDR Report Key8959878
MDR Text Key156428925
Report Number3007566237-2019-01887
Device Sequence Number1
Product Code NAM
Combination Product (y/n)N
PMA/PMN Number
K132561
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number3533
Device Catalogue Number3533
Was Device Available for Evaluation? No
Date Manufacturer Received11/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight77
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