MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD VERIFY; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	3531
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Codes	Micturition Urgency (1871); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from the consumer regarding a patient implanted for a trial evaluation.It was reported that the trial patient had not seen any results from the trial evaluation as of yet.The reporter stated that the patient would void around 300 and the would be a residual of 700-800.The patient would void 100% but still had residual when they had to catheterize.It was mentioned that the patient was unable to feel an urge to use the restroom.The reporter had contacted the manufacturer¿s representative about the issue and was told to call the manufacturer for suggestions.Options of the possibility of increasing the stimulation or changing sides were reviewed with the reporter.The reporter noted that the trial patient only had access to their current settings and was unable to change sides or adjust settings.They were currently set at 4.2 volts, presumably on the left side, and did not feel the stimulation.The reporter also noted that the patient had a clear substance coming from the incision site which started on the implant date of the trial ((b)(6) 2019).They wanted to know what this was but was redirected to the patient¿s healthcare professional (hcp) for the issue.It was further reported that the inside of the controller looked corroded like a ¿battery leaked¿ inside there.It was advised that they contact the hcp about the damage equipment.There were no further complications reported or anticipated.

• Brand Name: VERIFY
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• MDR Report Key: 8811079
• Report Number: 3004593495-2019-00722
• Device Sequence Number: 2657649
• Product Code: EZW
• UDI-Device Identifier: 00643169725072
• UDI-Public: 00643169725072
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2019

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
• Operator of Device: Health Professional
• Device Model Number: 3531
• Device Catalogue Number: 3531
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other