MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD VERIFY

Model Number	3531
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Unintended Collision (1429)
Health Effect - Clinical Codes	Pain (1994); Therapeutic Effects, Unexpected (2099)
Date of Event	03/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other applicable components are: product id: 3889-28, lot# va1d15l, product type: lead.Product id: 357664, lot# n675233, product type: screening device.
Event or Problem Description
Information was received from a consumer regarding a patient with an external neurostimulator (ens) for trial stimulation who reported that the patient had a change in sensation and leg pain after being in a car accident during their basic evaluation.The caller indicated that the patient was rear-ended by another vehicle and had their ens turned off while in the emergency room, but then turned it back on after discharge from the er.When the patient arrived at the hospital for their stage two procedure their healthcare provider (hcp) tested the trial lead and found that "amplitude levels" were higher than when the initial lead was placed.The hcp then confirmed that the lead had migrated deeper, the hcp removed the previous trial lead and placed the stage two lead with the implantable neurostimulator (ins).The lead issue was noted as resolved at the time of this report and a manufacturer representative (rep) noted that the stage two lead/system provided bellows and toe response on all electrodes.There were no further complication reported or anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERIFY
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• MDR Report Key: 6507122
• Report Number: 3004593495-2017-00247
• Device Sequence Number: 16476545
• Product Code: EZW
• UDI-Device Identifier: 00643169567764
• UDI-Public: 00643169567764
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 04/20/2017

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: 03/25/2017
• Supplement Date Received by Manufacturer: 03/25/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR