MAUDE Adverse Event Report: QUALITY TECH SERVICES LLC SENSIGHT

Model Number	B32000
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that in the middle of a bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) implant, the physician could not get the final cap/cover to fully attach to the burr hole device.The patient had a small skull causing greater than normal curvature.They tried to unlock and lock the scissor mechanism to make sure it was fully locked and tried clicking the cover down a dozen times.The physician decided not to use the cover and put a dog bone down next to the burr hole device to hold the lead. the first side went as planned. they then ran an impedance test and all looked normal.

• Brand Name: SENSIGHT
• Manufacturer (Section D): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• MDR Report Key: 12086391
• Report Number: 3012165443-2021-00006
• Device Sequence Number: 13861153
• Product Code: MHY
• UDI-Device Identifier: 00763000426521
• UDI-Public: 00763000426521
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/19/2023
• Device Model Number: B32000
• Device Catalogue Number: B32000
• Device Lot Number: 082M10921
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 57