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	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 3889, lot# unknown, product type: lead.Product id: 3889, serial/lot #: unknown.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 (ens) for trial stimulation who reported that the patient increased stimulation up to the maximum setting, but was no longer feeling stimulation.The patient indicated that they were instructed to use both sides for 2 days to evaluate and the patient had already previously been on the right side, but changed to the left side on (b)(6).After completing 2 days of evaluation the patient decided that they wanted to try the right side again to see if they would see better progress.Patient status is unknown at the time of this report.There were no further complication reported or anticipated.Follow-up with the patient's healthcare provider (hcp) determined that actions taken on (b)(6) 2018 were to manage behaviorally and that the cause of the loss of stimulation was "dislodged." 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.
Event or Problem Description
Follow-up with the patient's healthcare provider (hcp) determined that both sides were activated in an effort to resolve the loss of stimulation and the patient thought that the cause of the loss of stimulation was that it was dislodged.The hcp was not interested in a permanent implant and elected to use a behavioral approach.Patient status is unknown at the time of this report.There were no further complication reported or anticipated.

• 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: 7833881
• Report Number: 3004593495-2018-00811
• Device Sequence Number: 1703770
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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: 08/14/2018
• Supplement Date Received by Manufacturer: 09/09/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR