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

Model Number	3531
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Muscle Spasm(s) (1966); Discharge (2225)
Date of Event	09/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The main component of the system and other applicable components are: product id: 388928, implanted: (b)(6) 2017, product type: lead.Analysis of the lead identified that the #0, #1, and #3 conductor(s) were broken 10.1 cm from the distal end of the lead and no electrical shorts were identified between the circuits.Analysis observed the distal end of the lead was stretched.(b)(4) pertain to product id: 3531, serial (b)(4), product type: external electrical stimulator.(b)(4) pertain to product id: 388928, product type: lead.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 for advanced evaluation.It was reported that patient tried to increase stimulation and received the cannot provide desired settings at 5.2.They changed to program 2 and got the same message at 3.5.On program 3 they received the message at 2.3.There were no known contributing factors to this event.Further information was received that the patient was still seeing the unable to provide desired settings screen.No further complications were reported or anticipated.Additional information was received from a consumer.It was reported that the evaluation was not helping at all and the patient was not seeing improvements.The patient had some contractions and there was discharge yesterday, but none on the day of the report.The patient wanted to go over programs and stimulation; it was noted the patient was told to increase it three times a day.Additional information was received three days later.It was reported that the device was not working and it was clarified that it was the more the therapy itself.No further complications were reported/anticipated.Additional information was received that the device did not work and was going to be removed the following day.
Additional Manufacturer Narrative
Device code no longer pertains to product id 3531, serial# (b)(4), product type: electrical external stimulator.Device code corrected to pertain to product id 388928, lot# unknown, product type: lead.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7006925
• Report Number: 3004593495-2017-00643
• Device Sequence Number: 1157077
• 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,Followup,Followup,Followup
• Report Date (Section B): 01/03/2018

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: No Information
• Device Model Number: 3531
• Device Catalogue Number: 3531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 11/07/2017; 01/03/2018; 01/03/2018
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 11/09/2017; 01/03/2018; 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 91