MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN BILATERAL NEXFRAME; 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	10/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id 924256, lot# 082218417a, product type accessory.
Event or Problem Description
Information was received from a healthcare provider via a manufacturing representative about a patient with unknown indications for use.It was reported that the patient was undergoing stage 1 implant of a dbs system.The burr hole cover would not engage into the bone.The stereotactic head frame base was secured, but seemed to be very loose after it was aligned to the target.The surgeon tried tightening the burr hole cover screw more, but it would not engage.The stereotactic head frame screws would also not tighten into the bone.The burr hole cover screw was replaced, and the new screw worked well.The stereotactic head frame base was replaced with a new base using an extra screw from the first base which wouldn't tighten.The extra screw from the first base tightened into a rescue hole without issue.The issue was resolved at the time of the report.There were no symptoms reported.No further complications were reported or anticipated.
Additional Manufacturer Narrative
Analysis of the nexframe (lot no.082518417) found that the ring assembly screw thread was damaged.(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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN BILATERAL NEXFRAME
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 6917854
• Report Number: 3007566237-2017-04203
• Device Sequence Number: 1444163
• Product Code: HAW
• UDI-Device Identifier: 00643169214811
• UDI-Public: 00643169214811
• 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
• Report Date (Section B): 09/19/2018

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: 07/03/2018
• Device Model Number: DB-2040
• Device Catalogue Number: DB-2040
• Device Lot Number: 082518417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 10/17/2017; 11/21/2017; 09/19/2018
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 10/25/2017; 12/07/2017; 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 77