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

Model Number	3531
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product id: 3889-28, lot# va17p3x, product type: lead.(b)(4).
Event or Problem Description
A healthcare professional (hcp) reported via manufacturer representative (rep) that she was in the operating room (o.R) on the morning of the call.The rep stated the hcp decided to remove the old advanced evaluation lead and re-implant a new lead.The rep reported during the trial, the patient pulled on their lead.The rep noted the hcp implanted for a new lead and the patient was doing fine.There were no symptoms reported.Additional information from the rep reported the patient had completed an advanced evaluation and had the permanent device implanted on (b)(6) 2016.It was noted the patient had bi-lateral implants.The indication for use is unknown.
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: 6174419
• Report Number: 3004593495-2016-00578
• Device Sequence Number: 10991513
• Product Code: EZW
• UDI-Device Identifier: 00643169567764
• UDI-Public: 00643169567764
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2016

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
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: 11/22/2016
• Initial Report FDA Received Date: 12/14/2016
• Supplement Report FDA Received Date: 09/28/2017
• 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: 71 YR