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

Model Number	353101
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Connection Problem (2900); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information references the main component of the system.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 urge incontinence.It was reported that the trial patient tried to increase the stimulation but got a ¿maximum setting¿ message.Troubleshooting was unable to resolve this issue as a ¿connection error¿ message was then seen.Further troubleshooting did not resolve the issues.Follow up information received from the trial patient on (b)(6) 2019 reported that their device was still not working and was turned off.The patient contacted their clinician and they were not available until monday.Follow up information received from the manufacturer¿s representative on (b)(6) 2019 reported that the cause of the maximum settings/connection error was that the wires had pulled out from their initial placement.As a action taken, the hcp staff were completely removed.The issue was reported as 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: 8546153
• Report Number: 3004593495-2019-00378
• Device Sequence Number: 16243288
• Product Code: EZW
• UDI-Device Identifier: 00643169968783
• UDI-Public: 00643169968783
• 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: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 04/23/2019
• Initial Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR