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

Model Number	353101
Medical Device Problem Codes	Energy Output Problem (1431); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Malaise (2359)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 3889-28, lot# unknown, product type: lead.Product id: 3889-28, serial/lot #: unknown, ubd: unknown, udi#: unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer and a manufacturer¿s representative regarding a trial patient who was using an external neurostimulator (ens) for non-obstructive urinary retention.It was reported that the patient was not feeling very good.On a second call, the patient reported they were receiving the maximum settings error message on their programmer.On the call, they attempted to lower and raise stimulation and try a different program, but they were still receiving the same error.The patient was advised to contact their healthcare provider and their rep was made aware.On a third call the rep reported they were unable to increase the amplitude above 1.0ma.The rep stated 0, 1, and 2 were green, so they didn¿t understand why they couldn¿t get higher values for amplitude the day of the call.The rep also reported that they ran an impedance test and it showed an issue with contact 3.Troubleshooting could not be continued as the rep needed to go see the patient.It was reviewed that if impedances were high it would limit the amp value that could be achieved.The rep stated that program 7 was working for the patient the day of the call.It was reviewed to check connections with the percutaneous extension, but if things didn¿t resolve then they should consider the lead to be the issue.It was later reported that they decided to place a new lead on the other side and extend the trial.It was noted that the lead was removed intact.It was noted that the trial began on (b)(6) 2019.No further complications were reported.
Additional Manufacturer Narrative
Concomitant medical products: product id: 3889-28, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: unknown, ubd: unknown, udi#: unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the rep/hcp: this patients lead wire was removed entirely without injury and there was no impedance on the new lead.No further patient complications have been reported as a result of this event.

• Brand Name: VERIFY ENHANCED
• 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: 8315591
• Report Number: 3004593495-2019-00113
• Device Sequence Number: 154593
• Product Code: EZW
• UDI-Device Identifier: 00643169968783
• UDI-Public: 00643169968783
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2019

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: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 03/17/2019
• 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: 83 YR