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

Model Number 353101

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Muscle Spasm(s) (1966); Nerve Damage (1979); Pain (1994); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544); Electric Shock (2554); Alteration In Body Temperature (2682)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

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).Patient said they turned their device off because it was causing too much pain and it felt like they were "getting shocked" every 5 minutes.They added that they turned stimulation off and still felt the shocking and started having spasms.The patient noted that they had to "grab my private part" and almost screams.As a result of what was reported, they were redirected to their healthcare provider (hcp).The patient lastly noted that they were currently at the implanting facility so the call center recommended discussing concerns with medical staff.Additional information was received by the patient who noted the device was removed on (b)(6) 2020.They further noted that it damaged their nerves in the back and they want a settlement from the manufacturing company; they will be getting a lawyer.The patient said they are unable to function and now the caregiver is helping them out.They further noted that they had no symptoms and was able to walk the night of the trial, but now they can barely walk (can only take two or three steps).They alsosaid they get this sharp shooting pain all the way up and has developed sensitivity deficit every time they move their legs.The patient also reported that no matter what they do, they feel cold all the time.The consumer lastly noted that the healthcare provider (hcp) went too deep during the trial procedure.No further patient complications have been reported as a result of this event.

• 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: 9695156
• MDR Text Key: 189195853
• Report Number: 3007566237-2020-00223
• 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: 02/11/2020

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: 02/04/2020
• Initial Date FDA Received: 02/11/2020
• 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 Outcome(s): Congenital Anomaly; Disability