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); Therapy Delivered to Incorrect Body Area (1508); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Twitching (2172); Sleep Dysfunction (2517)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other applicable components are: product id: 3889, lot# unknown, 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 basic evaluation trial patient with an external neurostimulator (ens).The patient reported that they were not able to sleep the night before report because of the stimulation going up and down their buttocks/leg area, it felt like it was jerking.Additional information from the patient's healthcare provider (hcp) received on jan-23-2018 indicated that the cause of the stimulation issue was that the patient had pulled the lead partially out.The patient was switched to the other lead.Patient status is unknown at the time of this report.There were no further complication reported or anticipated.
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.
Event or Problem Description
The hcp reported that the lead dislodgement was non applicable and that the lead was a test lead and they move.The hcp reported that the issue was resolved and that the patient went get the permanent implant.

• 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: 7236868
• Report Number: 3004593495-2018-00004
• Device Sequence Number: 786349
• 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,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• 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: 01/23/2018
• Supplement Date Received by Manufacturer: 01/23/2018; 04/18/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 02/02/2018; 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR