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

Model Number	3531
Medical Device Problem Codes	Intermittent Continuity (1121); Failure to Deliver Energy (1211); Failure to Interrogate (1332); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	06/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other applicable components are: product id: 3537, serial# unknown, product type: programmer.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 a consumer (con) via a manufacturer representative (rep) regarding a trial patient.It was reported that it was not working at all.It was noted that the handheld controller wasn't working and they were unable to urinate.It was also reported that the device was turning off, so it couldn't be found by the controller.On (b)(6) 2017, it was reported that, in the office, the rep tried replacing the batteries and repositioning the batteries.Every time they would, the device would come on for 20 seconds and shut down again.The external neurostimulator (ens) was replaced and the patient's therapeutic benefit returned.There were no further complications reported or anticipated.
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: 6678518
• Report Number: 3004593495-2017-00376
• Device Sequence Number: 1971541
• 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: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2017

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
• Initial Date Received by Manufacturer: 06/10/2017
• Supplement Date Received by Manufacturer: 06/10/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 10/05/2017
• 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: Other
• Patient Age: 23 YR