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

Model Number	3531
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 3057; product id: 3057.Trial leads implanted (b)(6) 2018, exact explant date not known (approx.A week later).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 a basic evaluation trial device to treat urge incontinence and urgency frequency; the trial began (b)(6) 2018.On (b)(6) 2018 it was reported the trial patient was uncomfortable on her right side.Also, her device was displaying "settings unavailable, call your clinician".The manufacturer's representative was flagged to call the patient to help her switch sides back.On (b)(6) 2018 the manufacturer's representative reported the healthcare professional informed them that the cause of the "settings unavailable, call your clinician" was due to the wires had moved slightly.The "settings not available" seen on the external device was not resolved as the trial leads were removed.The patient's discomfort resolved.No further complications were reported or are 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: 7466446
• Report Number: 3004593495-2018-00429
• Device Sequence Number: 144904
• Product Code: EZW
• UDI-Device Identifier: 00643169725072
• UDI-Public: 00643169725072
• Combination Product (Y/N): N
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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: 02/21/2018
• Initial Report FDA Received Date: 04/26/2018
• 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: Required Intervention
• Patient Age: 85 YR