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

Model Number 353101

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Skin Irritation (2076); Discomfort (2330)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from the consumer regarding a patient with a trial external neurostimulator (ens) for urge incontinence patient reported that her #2 lead is broken or loose and she is on her way to the clinic now to have it examined.Patient mentioned discomfort from skin irritation.No further complications were reported or 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
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9626749
• MDR Text Key: 176862517
• Report Number: 3007566237-2020-00119
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/24/2020
• 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 Age: 73 YR