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

Model Number	MI-1000
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	04/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare provider via a manufacturing representative about a patient being implanted with dbs therapy for unknown symptoms.It was reported that during the patient¿s implant procedure the micro electrode recording (mer) collar had a tight hole that would not allow the mer to pass through.The implanting surgeon used a different mer collar that comes in the kit to finish the surgery without a problem.There were no symptoms reported.No complications or further complications were reported.
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.(b)(4).
Additional Manufacturer Narrative
Product analysis: product id# mi-1000.Analysis identified that the mer collet was malformed.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.
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: 6530305
• Report Number: 3007566237-2017-01642
• Device Sequence Number: 10934570
• 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: K012366
• 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,Followup
• Report Date (Section B): 07/24/2017

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: 05/20/2017
• Device Model Number: MI-1000
• Device Catalogue Number: MI-1000
• Device Lot Number: 082614116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: Not provided; 07/20/2017; 07/20/2017; 07/20/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 05/05/2017; 07/24/2017; 10/03/2017; 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: 62 YR
• Patient Weight: 59