MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION VERIFY; STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION

Model Number 3531

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Incontinence (1928); Pain (1994); Sleep Dysfunction (2517)

Event Date 06/06/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3537, product type: programmer, patient.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

A patient reported that they were experiencing sudden, painful urination and stimulation is adversely affecting their bowel movements.They decreased stimulation from.9 to.8 and it seemed to help, but the morning of the report they woke up again and the pain was back.They decreased stimulation again to.7v.The manufacturing representative was notified of the troubleshooting performed during the report.The symptoms reported included, pain that caused them not to be able to sleep, painful urination, decreased urinary output, and runny bowel movements the patient can't control.On 2016-jun-16, follow up information from the patient stated the patient has a painful urge that they say is not from the implantable neurostimulator (ins).They also can't change programs on their verify controller.On 2016-jun-22, follow up information was received from the clinician that stated the issues of painful urination, decreased urinary output, and the runny bowel movement have been resolved without intervention.

Manufacturer Narrative

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

• Brand Name: VERIFY
• Type of Device: STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION
• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5778863
• MDR Text Key: 49064149
• Report Number: 3007566237-2016-02547
• Device Sequence Number: 1
• Product Code: NAM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• 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
• Date Manufacturer Received: 06/15/2016
• 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