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

Model Number	353101
Medical Device Problem Codes	Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Diarrhea (1811); Flatus (1865); Pain (1994)
Date of Event	03/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 3057, serial/lot #: unknown, implanted: (b)(6) 2019, product type: screening.(b)(4).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 trial patient who was implanted on (b)(6) 2019 for a verify enhanced basic evaluation (be) for fecal incontinence.It was reported that the trial patient was hurting through church (¿just pain¿).They also reported that they had diarrhea and a lot of gas.Additional information received on (b)(6) 2019 from the trial patient reported that they were not seeing 50% or greater reduction in symptoms so it was advised to switch to the right side.The patient stated that the right side ¿doesn't work¿.They did not feel any stimulation and they ¿maxed out¿ on their settings.The patient stated that they were to stay on the left side throughout the evaluation and no therapy changes were made.It was unknown if there were any environmental/external/patient factors that may have led to the issue.It was advised that the patient contact their clinician for the issue.It was unknown if the issue was resolved at the time of report.It was unknown if any surgical intervention had occurred or if any were planned.The patient status was noted as ¿alive ¿ no injury¿.Follow up information received from the healthcare professional (hcp) on (b)(6) 2019 reported that the cause of the trial patient¿s issues was that ¿it was felt that the right lead may have moved¿ during the testing.As an action taken to resolve the issue, the patient was switched to the left side for the remainder of the testing.The hcp reported that the patient issues were resolved.There were no further complications reported or anticipated.

• Brand Name: VERIFY ENHANCED
• 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: 8505689
• Report Number: 3004593495-2019-00329
• Device Sequence Number: 13914787
• Product Code: EZW
• UDI-Device Identifier: 00643169968783
• UDI-Public: 00643169968783
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P080025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR