MAUDE Adverse Event Report: ADVANCED URO-SOLUTIONS, L.L.C. NEXDRIVE; INSTRUMENT, STEREOTAXIC

Model Number	MI-1000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2018
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
Information was received from a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported during the procedure the tube collet on the nexdrive was very tight while inserting the alpha omega micro cannula.No environmental/external/patient factors were thought to have led or contributed to the issue.The physician was able to insert the tube correctly but noted a very tight fit much more than usual.No troubleshooting was done and the issue was resolved at the time of the report.The patient was alive without injury at the time of the report.No complications were reported or anticipated.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the nexdrive revealed the returned device passed all testing in the laboratory and no anomalies were identified.(b)(4) no longer apply.(b)(4) now apply.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: NEXDRIVE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): ADVANCED URO-SOLUTIONS, L.L.C.; 7842 hickory flat highway; suite d; woodstock GA 30188
• MDR Report Key: 7686941
• Report Number: 3012165443-2018-00008
• Device Sequence Number: 2643344
• Product Code: HAW
• UDI-Device Identifier: 00613994747853
• UDI-Public: 00613994747853
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 10/23/2018
• Device Model Number: MI-1000
• Device Catalogue Number: MI-1000
• Device Lot Number: 082629617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 08/10/2018; 08/08/2018; 10/04/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/15/2018; 10/03/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 82