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

Model Number 353101

Device Problems Failure to Deliver Energy (1211); Environmental Compatibility Problem (2929)

Patient Problems Pain (1994); Urinary Retention (2119); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 11/09/2021

Event Type  Injury  

Event Description

Information was received from an advanced evaluation trial patient who was using an external neurostimulator (ens) for urge incontinence.The trial began (b)(6) 2021.It was reported that the patient was sore on the side where they took the lead out.The issue was not resolved at the time of the report.Two days later, they stated it felt like they were not emptying their bladder all the way.They had fallen a couple of times and hit their head.They were not feeling the stimulation, and had no pain on the left side, but had pain on the right side, and were still not able to lie down; they were standing up a lot.They were advised to contact their clinician for advice and with concerns.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERIFY ENHANCED
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12957852
• MDR Text Key: 284177783
• Report Number: 2182207-2021-02121
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• 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
• Date Manufacturer Received: 11/09/2021
• 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: 51 YR
• Patient Sex: Female