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

Model Number	3531
Medical Device Problem Codes	Failure to Deliver Energy (1211); Installation-Related Problem (2965)
Health Effect - Clinical Codes	Micturition Urgency (1871); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119)
Date of Event	08/09/2018
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 a consumer regarding a patient with an external neurostimulator.It was reported that the patient stopped feeling stimulation.The patient mentioned that he had changed between a couple of programs.Troubleshooting attempts were made and stimulation was on.It was noted that the patient was set to program 7 at 8.0.On (b)(6), the patient reported that the patient saw the message that the device was not set up properly for the patient's use, "contact your clinician.Turn off therapy/end session".The patient confirmed that the trial was working well and it was making him pee more with a good flow but now he was peeing less and had the urge to go again but nothing comes out.The patient was redirected to his health care professional.There were no further symptoms or 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: 7855789
• Report Number: 3004593495-2018-00845
• Device Sequence Number: 11120590
• Product Code: EZW
• UDI-Device Identifier: 00643169725072
• UDI-Public: 00643169725072
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/07/2018

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
• 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: 08/10/2018
• Initial Report FDA Received Date: 09/07/2018
• 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