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

Model Number 353101

Device Problems Failure to Deliver Energy (1211); Unintended Collision (1429); Device Displays Incorrect Message (2591); Battery Problem (2885); Device Dislodged or Dislocated (2923); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)

Patient Problems Fall (1848); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an external neurostimulator for urge incontinence.It was reported that the patient had a bad night.The patient fell down, woke up with dislodged wires, and wet all over.The patient's husband helped the patient to get up and connected the wires.The patient wasn't feeling the stimulation and the therapy was off.During troubleshooting, the patient showed there was a connection with the device.The stimulation was increased until it was felt.The healthcare professional (hcp) has been contacted.On (b)(6), the patient reported seeing an error message; settings not available (59), cannot provide desired intensity settings, contact your clinician.It was also reported that the patient doesn't feel the stimulation.During troubleshooting, it was noticed that the controller battery level was at 75% and the ens battery level was at 100%.The amplitude was decreased to 0.0ma and increased to 7ma, but didn't resolve the issue.The patient was on 1.0 when the settings not available screen came up.The stimulation was decreased to 0.0, then back up and the settings not available screen came back up at 0.7.There were no further complications or anticipations reported with this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7728875
• MDR Text Key: 115536237
• Report Number: 3007566237-2018-02252
• Device Sequence Number: 0
• Product Code: EZW
• 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,Followup
• Report Date: 10/04/2018

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/27/2018
• 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: 78 YR