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

Model Number	3531
Medical Device Problem Codes	High impedance (1291); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Incontinence (1928); Therapeutic Effects, Unexpected (2099); Urinary Frequency / Polyuria (2275)
Date of Event	01/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product id: neu_unknown_lead, serial# unknown, product type: lead.Product id: neu_unknown_ext, serial# unknown, product type: extension.
Event or Problem Description
Information was received by a manufacture representative and a trial patient for an explantable neurostimulator (ens).Manufacture representative reported a screen 59 (settings not available) on programs 1 (0- 3+), 2 (2- 3+) and 4 (0+ 3-).Representative already wiped down and dried off the twist lock cable and made sure everything was secure and tried a different ens with no resolution; the first ens was used.It was advised to decrease amplitude to 0.0ma and increase amplitude to effect on the ens.An open circuit was considered.The connection of perc extension and twistlock were checked and seated properly.The twistlock was changed out, but the screen 59 issue was still present.0-3 was tested again and got screen 59 at 0.2 ma.1-2 combination was tested again and manufacture representative was able to increase to 0.9 ma and patient felt stimulation.It was reviewed that the issue was most likely with the lead, but there's no way of telling if the problem isn't the extension.It was reviewed to leave everything as is and continue trial without using contact 3 or consider replacing the lead to ensure that contact 3 can be used for programming.Patient reported a loss or change of therapy.Caller says the trial is not helping a whole lot, but the patient said they got some relief.Patient reported leakage is the same or worse and is going to the bathroom the same (less than an hour apart and 50-60 ml at a time).Patient was on 1.2v, but increased stimulation to 1.9v.It was advised to have the patient call back if it does not get better.Patient went to the doctor on (b)(6) 2017.
Additional Manufacturer Narrative
Product id: 3889-28, serial# (b)(4), product type: lead.
Event or Problem Description
Serial numbers of the lead was obtained.
Event or Problem Description
Additional information was received.It was reported that electrode three was causing an open circuit.

• 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: 6247483
• Report Number: 3004593495-2017-00001
• Device Sequence Number: 862261
• Product Code: EZW
• UDI-Device Identifier: 00643169567764
• UDI-Public: 00643169567764
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 01/17/2017

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: 01/12/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 01/12/2017; 01/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1