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

Model Number 3531

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Diarrhea (1811); Flatus (1865); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Vomiting (2144); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Constipation (3274)

Event Date 07/23/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacture representative (rep) via an (b)(6) trial patient regarding an external neurostimulator (ens).Patient said they were very gassy.The next day, patient said they were feeling ill and were vomiting.As a result, they were redirected to their healthcare provider (hcp).On (b)(6) 2017, patient said one of their stitches got infected and there was some bleeding.The patient said their buttocks have been hurting for about a week.When they were passing a bowel movement, they had to push really hard.Three days later, patient had gas and stomach aches so they were advised to decrease stimulation.They had to go to the er because their bandage was coming off.On (b)(6) 2017, patient complained of cramping, increased bowel movements, and leaking.They went to the er to have their bandage changed as it completely came undone.On (b)(6) 2017, the patient saw their hcp because they felt that "something is not right" and the hcp told them a wire is completely out.The patient also expressed concern with the color of their bowel movement.No further patient complications have been reported as a result of this event.

• 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: 6793982
• MDR Text Key: 82681810
• Report Number: 3007566237-2017-03288
• 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: Other
• Type of Report: Initial
• Report Date: 08/15/2017

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: No Information
• 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: 07/23/2017
• Initial Date FDA Received: 08/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR