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

Model Number 353101

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Erythema (1840); Fainting (1847); Fatigue (1849); Fever (1858); Flatus (1865); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Itching Sensation (1943); Muscle Spasm(s) (1966); Pain (1994); Urinary Retention (2119); Weakness (2145); Hot Flashes/Flushes (2153); Distress (2329); Discomfort (2330); Complaint, Ill-Defined (2331); Irritability (2421); Cognitive Changes (2551); Constipation (3274)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3057, lot #: unknown, product type: screening device.Product id: 3057, lot #: unknown, product type: screening device.Other relevant device(s) are: product id: 3057, serial/lot #: unknown, ubd: unknown, udi #: unknown.Product id: 3057, serial/lot #: unknown, ubd: unknown, udi #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a trial patient who was using an external neurostimulator (ens) for urge incontinence and fecal incontinence.It was reported that the patient switched to the left side the day before and since then had a higher urge to void.The patient stated that they had some bowel leakage.The patient also stated it was still sore at the incision site and it was itching all over their bike seat area.The patient experienced a little pain after they bent down to get a bottle of water from the floor.The patient noted the device seemed to be helping with their bladder spasms.It was recommended that the patient lower stimulation to see if it would help the itching sensation.The patient was advised to contact their healthcare provider.It was noted that the trial began on (b)(6) 2019.On a second call, the patient reported they were itchy now that they switched to the left lead near the lead site and they didn¿t feel itching on the right side.The patient also reported that they were having accidents and diarrhea.The patient also mentioned soreness from the procedure and bladder spasms.On (b)(6) 2019 the patient stated they spoke with their nurse and they told them the itching is probably caused from the tape.The patient stated that last night they had bladder pain and were unable to urinate even though they had a strong urge to urinate.She believes this is from a prescription she was taking called hydroxyzine.On (b)(6) 2019 the patient reported they had a rough day the day before, since they switched to the left side their bladder and bowel had been bothering them, it was making their symptoms worse.The patient noted having 5 accidents on the left side in the last 24 hours but on the right side was able to make it to the restroom.The patient noted they had never had accidents so bad.The patient also reported their bladder was not feeling well and that they took an antibiotic from their clinician and when they would have the urge to void they were unable to.The patient again reported they were very itchy and were given benadryl, and their stool would not come out.On (b)(6) 2019 the patient reported that their nurse told them they may have an infection as they were itchy, had redness near their lead, had no energy, and just felt bad.The patient noted their symptoms had been better since switching to the right side.They noted they had no fever, but they had diarrhea, bladder pain, bladder spasms, and constipation.The patient reported they got a strong urge to urinate with pain but couldn¿t void.The patient also noted their hormones were out of order.On (b)(6) 2019 the patient mentioned that they thought the leads were infected as they had a fever.The patient stated they couldn¿t think straight.The patient stated that they had diarrhea, their symptoms worsened on the left side, and they had bladder spasms.The patient stated they attempted to turn up their stimulation, but it was painful.The patient stated they felt very weak and the evaluation caused too much stress for their body.The patient felt pain in their vaginal area, and different drinks agitate their bladder.The patient stated that the wires and battery pack were agitating.The patient stated that the procedure was painful, caused them hot flashed, and they fainted from it, and they had gas.No further complications were reported.

Manufacturer Narrative

Concomitant medical products: product id: 3057, lot# unknown, product type: screening device.Product id: 3057, lot# unknown, product type: screening device.Other relevant device(s) are: product id: 3057, serial/lot #: unknown, ubd: unknown, udi#: unknown.Product id: 3057, serial/lot #: unknown, ubd: unknown, udi#: unknown.H6: device code: c76126 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.

Event Description

Additional information was received from the patient on 2019-jun-06.It was reported the trial patient mentioned that her ens belt is uncomfortable and bothering her.She also mentioned soreness at the incision site.She mentioned bladder spasms, diarrhea, and the opposite of that (presumably constipation).Patient mentioned that she pulled a wire out when moving her belt.On (b)(6) 2019 the patient stated that the evaluation is helping with her bladder spasms.The patient stated that she charged her programmer as the device batteries were low.The patient stated that she thinks she may have done something to her device and messed it up.The patient stated that her stool description is like diarrhea and that she took a laxative for her constipation.The patient stated that when she went to have a bowel movement it hurt near the incision site.The patient stated that her stimulation was stinging.She lowered it to a comfortable level.The patient stated that they moved the ens and belt and are more comfortable as she had pulled on it yesterday.She stated that the belt was aggravating.No further complications were reported or are anticipated.

• 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: 8754028
• MDR Text Key: 149817797
• Report Number: 3007566237-2019-01452
• 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
• Report Date: 07/02/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 06/08/2019
• Supplement Dates FDA Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR