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 Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Therapeutic Response, Decreased (2271); Urinary Frequency / Polyuria (2275)
Date of Event	10/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other applicable components are: product id: 309101 lot# 51026657, product type: screening device.Product id: 305901, lot# 60056391, product type: screening device.(b)(4).Conclusion: applies to screening device (lot#s 51026657 and 60056391) only.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from the manufacturer¿s representative regarding a trial patient who was implanted for basic evaluation (be).It was reported that the trial patient¿s frequency had come back and turning up the stimulation caused them pain.Therapy sides were changed.The issue was reported as not resolved at the time of report.It was unknown if any surgical intervention had occurred or was planned.The patient status was noted as ¿alive ¿ no injury¿.Additional information received from a manufacturer representative (rep).The cause of the patient's pain when stimulation was increased was the wires migrated so they were removed.The issue was resolved at the time of the report.Additional information received from the rep who clarified the "wires migrated" was in reference to the leads.Device information was provided.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Event now treated as a system report.Eval code-conclusion is no longer applicable.Patient codes and device codes applies to screening device (lot#s 51026657 and 60056391) only.If information is provided in the future, a supplemental report will be issued.

• 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: 7094944
• Report Number: 3004593495-2017-00769
• Device Sequence Number: 11107312
• 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: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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: No Information
• 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: 12/07/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR