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

Model Number	3531
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Malposition of Device (2616); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)
Date of Event	02/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product id: neu_unknown_lead, serial# unknown, product type: lead.
Event or Problem Description
The trial patient reported that felt "shock or shooting in their left buttock" whenever the external neurostimulator stimulator (ens) was turned on or they change sides even when the voltage was set to zero.Representative tried new controller and took batteries out of ens but patient still felt stimulation anytime they went to unlock anything even though it showed zero volts.Technical services advised representative to try another ens and patient still felt same sensation when turning on ens.A placebo test was done and patient did not feel anything until they turned ens on again.Representative turned up stimulation and patient has very low threshold on left lead.Patient felt it on left side at 0.2v.Left lead was probably too close to nerve and very sensitive to stimulation.Right lead was comfortable at 1.1v so they will continue trial with right lead.The symptom reported was indicated as sudden.Patient felt surge when ens was turned on.It was later reported that ens was not malfunctioning they used the ens on the next basic evaluation.
Additional Manufacturer Narrative
Product id: neu_unknown_lead, serial# unknown, product type: lead.
Event or Problem Description
Additional information was received from a manufacturer representative.The representative reported that the shocking in the left buttocks was caused by the left lead being too close to a nerve.When they changed the ens out for a different, the symptoms remained the same.As an intervention, the ens was programmed so that the stimulation was only delivered to the right side lead during the basic evaluation.

• 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: 6337755
• Report Number: 3004593495-2017-00114
• Device Sequence Number: 19049667
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2017

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: 02/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1