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

Model Number	3531
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Codes	Embolism (1829); Pain (1994)
Date of Event	03/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received regarding a trial patient.Manufacturer representative reported the basic evaluation was performed with nothing out of the ordinary.When the patient turned their device up to about 3.0 they were not feeling stimulation.The patient then held the down arrow to return the amp to 0.0.Once that was accomplished the patient attempted to stand and resume increasing the ens.However this time, they appeared to whence in pain and almost buckled on their left side.They tried again to support their weight with their left side, but was unsuccessful.As time went on, 10-15 minutes, patient reported the severity increased.A ct scan was performed and it was determined that the patient had ¿a small piriformis embolism.¿ it was reported that the patient would be given both antibiotics and over the counter meds and would resume the trial in a day or two.No cause was known.No further complications reported/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: 7385269
• Report Number: 3004593495-2018-00139
• Device Sequence Number: 13801247
• 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
• Report Date (Section B): 03/30/2018

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: 03/28/2018
• Initial Report FDA Received Date: 03/30/2018
• 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