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

Model Number	3531
Medical Device Problem Codes	Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	06/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other applicable components are: product id: 3057, lot# unknown, product type: screening device.Product id: 3057, lot# unknown, product type: screening device.(b)(4).Eval -conclusion: applies to leads (lot#s unknown) only.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from the consumer regarding a patient with trial device system which started today.The family member reported the trial patient did not feel the stimulation.There was not a change in therapy related to positional movement.Also, no falls or trauma were reported that could be related to the issue.The stimulation on the right side had been increased up to 9.0 but the patient did not feel the stimulation.The stimulation was changed to the left side but the patient did not feel the stimulation when turned up to as high as it would go.Using the programmer, it was reported the therapy was on but the trial patient did not feel the stimulation in the correct bike seat area.There were no further complications reported or anticipated.Additional information was received from the manufacture representative (rep).The cause of not feeling stimulation on either side was determined.The patient is obese and the wires migrated out of the foramen before the patient left the hospital.As a result of the lead migration, the patient is moving onto the advanced evaluation.The not feeling stimulation issue was resolved.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Other applicable components are: product id: 3057, lot# unknown, product type: screening device.Product id: 3057, lot# unknown, product type: screening device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the manufacture representative (rep).Patient weight and lead lot numbers involved with the event are not known.No further patient complications have been reported as a result of this event.

• 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: 6753831
• Report Number: 3004593495-2017-00379
• Device Sequence Number: 163261
• Product Code: EZW
• UDI-Device Identifier: 00643169725072
• UDI-Public: 00643169725072
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2017

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: 07/06/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1