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

Model Number 3531

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Fainting (1847); Vomiting (2144); Weakness (2145); Complaint, Ill-Defined (2331); Malaise (2359); Sleep Dysfunction (2517)

Event Date 09/30/2019

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 consumer regarding a basic evaluation trial patient with an external neurostimulator (ens) for urge incontinence and urgency frequency.It was reported by a basic evaluation patient that they were up all night in the bathroom.The patient stated they had really bad stomach pain and they were throwing up.The patient stated that when they went to get up they fainted.On (b)(6) 2019 the patient called the inbound line and stated they were out of it and not feeling well.The patient reported they had a head cold and that they were very weak as well.The patient could not give their data at this time due to the way they felt.On (b)(6) 2019 the patient stated that they were not feeling too well on (b)(6) 2019.There were no further complications reported.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERIFY
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 9241174
• MDR Text Key: 165561096
• Report Number: 3007566237-2019-02212
• 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: 01/14/2020

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: 3531
• Device Catalogue Number: 3531
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR