MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 353101

Device Problems Failure to Interrogate (1332); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Battery Problem (2885); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)

Patient Problems Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Tract Infection (2120); Complaint, Ill-Defined (2331); Malaise (2359); Fungal Infection (2419); Sleep Dysfunction (2517); Alteration In Body Temperature (2682)

Event Date 01/08/2019

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 trial patient with an external neurostimulator (ens) for urge incontinence.The trial started on (b)(6) 2019.The patient stated that she went to her doctor's office during the morning as the blood from her incision site had leaked through her bandage and she had to change clothes several times.The patient also stated she was not feeling well and that the wires had come unplugged from her ens.She plugged them back in.Additionally, the patient mentioned she had a trip to er, she was in pain, but the er doctor stated that there was no infection or redness.They did change the bandage.She had felt pain in her buttock, toe and her arm.The patient has not slept for the last 2 nights.She mentioned "to" that she was hot and needed to take off her sweatshirt.Now the stimulation was directly on her vagina, when prior to the er it was on the left side of her vagina.Patient stated that she was groggy after the procedure.The battery life on her device was low and she charged the device and it turned completely off.Now when trying to increase stimulation it places her at a max threshold and cannot increase stimulation.She was experiencing more leaks, and her urgency was now at a 5 urgency constantly.She felt that her symptoms were worsening.She was unsure if she was sick or has a bug.Patient even mentioned that she had no urgency with her bowels.Patient went to urinate and had a huge bowel movement and wasn't even aware that it was going to occur.Patient was not seeing the 50% or greater so they switched her to program 2 and she was feeling stimulation at.1; when she tried to increase it to.2, the error message of max threshold came up again, now on the second program.The patient further stated that she was happy to be getting the implant because she was always bumping the wires that stick out and it would hurt.The patient stated that her device was not connecting with her controller.She stated it has happened before and she was leaking very bad.She also stated that she had a bladder infection and a uti at that time.She stated she had a vaginal yeast infection and was taking medicine for that.Patient also stated that one of the urinary leaks she had was a very weird color.No further complications were reported or are 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 was received from the manufacturer's representative (rep) and the hcp: the cause of the stim in the wrong loc ation during trial was not determined, and no actions were taken regarding this.The cause of the device not connecting and they could not increase stimulation was not determined, and the rep guessed the twist lock cable was not working or perhaps the extension wire came loose within the cylinder of the twist lock cable or the extension and lead were not connected well.The device not connecting, unable to increase stim was resolved at implant when the twist lock cable and extension wire were removed.All impedance checks with the lead connecting to the implanted battery were clear.It was unknown whether the patient's vaginal infection was due to the trial device/therapy or an underlying medical condition.No further complications were reported or are anticipated.

Event Description

Additional information was received from the healthcare professional (hcp): the uti and bladder infection were not related to the reported event.The patient's symptoms cleared after the phase ii implant, bladder infection and uti and stim in the wrong location, device not connecting and unable to increase stimulation were resolved.No further complications were reported or are anticipated.

Manufacturer Narrative

Patient code c50791 no longer applies.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.

• Brand Name: VERIFY ENHANCED
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8294208
• MDR Text Key: 134646970
• Report Number: 3007566237-2019-00255
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 03/11/2019; 04/06/2019
• Supplement Dates FDA Received: 04/04/2019; 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 133