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

Model Number 3531

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Urinary Frequency (2275); No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.Concomitant medical products: product id: 3057, lot# unknown, product type: screening device.The main component of the system.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 by a trial patient regarding an external neurostimulator (ens) indicated that his wires were dislodged.There was no intervention performed and the issue was not resolved at the time of this report.The patient indicator for use were for urge incontinence and urgency frequency.

Manufacturer Narrative

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
• 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: 7716523
• MDR Text Key: 115367041
• Report Number: 3007566237-2018-02202
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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: 3531
• Device Catalogue Number: 3531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• 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: 79 YR