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

Model Number	DB-2040
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2018
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 health care provider (hcp) via a manufacturer's representative (rep) regarding a patient who was implanted with an implantable neuro stimulator (ins).It was reported that during surgery the nexframe assembly was not moving smoothly when the doctor was adjusting it.There were no external environmental or patient factors that may have led or contributed to the issue that were reported.The doctor continued to try to work with the original assembly but felt it was affecting their ability to be accurate.It was reported that the nexframe was replaced with a new assembly kit, the new assembly moved more smoothly than the first and the issue was resolved.No patient symptoms were reported.No further patient complications were reported/ anticipated as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected (b)(4) because this is the closest code available with respect to this event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the nexframe lot # 082503818 found that the anatomy alignment ring rotates without indexing.If information is provided in the future, a supplemental report will be issued.

• 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: 7435945
• Report Number: 3012165443-2018-00003
• Device Sequence Number: 1718342
• Product Code: HAW
• UDI-Device Identifier: 00643169214811
• UDI-Public: 00643169214811
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/22/2018

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: 02/07/2019
• Device Model Number: DB-2040
• Device Catalogue Number: DB-2040
• Device Lot Number: 082503818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 04/17/2018; 06/07/2018; 06/13/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 04/21/2018; 06/15/2018; 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 57