MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEXDRIVE; INSTRUMENT, STEREOTAXIC

Model Number	MI-2000
Medical Device Problem Codes	Break (1069); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare provider (hcp) via a manufacturer representative (rep) reported that the measurement tape was misaligned on the micro-positioning system.The misalignment between red and blue color was not exactly at zero.No troubleshooting or diagnostics were reported.No actions were taken to resolve the issue.The issue was resolved at the time of this report.No medical symptoms were reported.The patient was implanted for unknown symptoms.
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the stereotactic headframe (lot #082632116a) found that the scale was out of alignment.Fdr code (b)(4) has been replaced by fdr codes (b)(4) and (b)(4).If information is provided in the future, a supplemental report will be issued.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): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 6849814
• Report Number: 3007566237-2017-03708
• Device Sequence Number: 68384
• Product Code: HAW
• UDI-Device Identifier: 00613994747860
• UDI-Public: 00613994747860
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/29/2018

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 Model Number: MI-2000
• Device Catalogue Number: MI-2000
• Device Lot Number: 082632116A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 09/11/2017; 10/24/2017; 03/28/2018
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 09/18/2017; 11/06/2017; 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR