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

Model Number 353101

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Failure to Interrogate (1332); Communication or Transmission Problem (2896)

Patient Problems Abdominal Pain (1685); Headache (1880); Itching Sensation (1943); Urinary Retention (2119); Anxiety (2328); Distress (2329); Discomfort (2330); Depression (2361); Constipation (3274); Insufficient Information (4580)

Event Date 04/16/2021

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 trial patient who was using an external neurostimulator (ens) for fecal incontinence and urge incontinence.The trial began (b)(6) 2021.It was reported that both sides of the patient's arms were itchy, they didn't know if it was from a rash or what.Contributing factors, actions/interventions and resolution were unknown.Additional information was received.The patient reported they had had a headache for 2 days.They mentioned they were not uncomfortable with the stimulation, but they had tried to turn it up to 1.1 volts and they no longer felt it.They had not yet been able to measure voids or fluid intake diary yet.Additional information was received.The patient reported they were having a medical crisis, they were having headaches and severe anxiety and they weren't sure why.They said their temporal lobes felt bruised.Additional information was received from the patient.They reported that in the beginning of the evaluation the patient had experienced constipation and believes this was from taking 3 pain tablets.Patient mentioned the next day after taking stool softeners, they had soft stool but not diarrhea.Patient said beforehand, they were frustrated with lack of bowel control but is happy with the improvements they are seeing.The patient talked about constipation and not being able to void, if the therapy can cause this.The patient mentioned that they are anxious 24/7 and contributed that to a supplement they are taking.The patient mentioned that they haven't had a bowel movement yet and is becoming concerned.The patient mentioned being in some discomfort when they have to wait to void.The patient was advised to speak with his doctor about their health concerns.Since they had this device, their stomach has been "tied in knots".The patient is feeling stressed out over all about this.They feel that this may be caused from other health issues they have.This is also causing pain and anxiety.The patient is feeling that if they has to leave this device in for too long, they will get an infection.They are going to see their gastroenterologist today and will be going to the hospital for some tests.Additional information was received from the patient.They reported that the programmer is not working.The patient was charging their programmer and support link assisted the patient with turning on the device but, the patient received a communication error.The patient will check their bandage to see if the lead coming out or if blood is on their bandage.The patient has depression and anxiety.The patient has stomach pain and acid burning their stomach and went to the emergency room.The patient had an mri of their stomach during the evaluation which they believe may have interfered with the functioning of their device.The patient is taking pain medication and has become constipated.Support link advised the patient to please contact their clinician with questions regarding medical advice or if they have questions about their health.

• Brand Name: VERIFY ENHANCED
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11850602
• MDR Text Key: 251540711
• Report Number: 2182207-2021-00847
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/19/2021

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: 04/23/2021
• Initial Date FDA Received: 05/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR