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

Model Number 353101

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Confusion/ Disorientation (2553); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 306001 lot# unknown serial# implanted: explanted: product type: screening device.Product id 309201 lot# unknown serial# implanted: explanted: product type: screening device.Information references the main component of the system.Other relevant device(s) are: product id: 306001, serial/lot #: unknown, ubd: , udi#: ; product id: 309201, serial/lot #: unknown, ubd: , udi#:.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 urge incontinence.It was reported that she was worried she had moved the wire.The issue was not resolved at the time of the report.

• 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: 13343171
• MDR Text Key: 284518720
• Report Number: 2182207-2022-00113
• 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: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 01/21/2022
• Initial Date FDA Received: 01/25/2022
• 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: 74 YR
• Patient Sex: Female