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

Model Number 353101

Device Problems Break (1069); Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Appropriate Term/Code Not Available (3191)

Patient Problems Discomfort (2330); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 306001, lot#: unknown, implanted: (b)(6) 2021, product type: screening device.Product id: 306001, lot#: unknown, implanted: (b)(6) 2021, product type: screening device.Product id: neu_unknown, serial#: unknown, product type: unknown.Other relevant device(s) are: product id: 306001, serial/lot #: unknown, ubd: , udi#:.Product id: 306001, 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 basic evaluation trial patient who was using an external neurostimulator (ens) for urge incontinence/fecal incontinence.It was reported by the basic evaluation patient that their "butt" was a little sore.On (b)(6) 2021, the patient stated "where those patches are, they are absolutely itching me to death." the patient noted they were scratching on top of the patches and they were wondering if that was ok.Support link referred the patient to their health care professional (hcp) for medical advice and health questions.That same day, the patient stated that the programmer had an error that stated one of the leads were not attached.The patient stated they noticed that the ens device was turned off.The patient was able to turn it back on and after this, the patient stated they still had the error.Support link attempted to have the patient restart the device and this did not help.The patient also stated that the green light on the ens kept turning off.The patient was advised to contact their health care professional (hcp) or the manufacturer representative (rep) to fix the issue.On (b)(6) 2021, the patient stated that their leads had broken and that they were unable to get a hold of their health care professional (hcp).

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12200777
• MDR Text Key: 262637222
• Report Number: 2182207-2021-01277
• 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: 07/20/2021

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: 07/15/2021
• Initial Date FDA Received: 07/21/2021
• 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 Age: 68 YR