MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION STEALTH AUTOGUIDE SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	29631
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 28324, serial/lot #: unknown, ubd: unknown, udi#: unknown.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system and automated trajectory guidance unit being used for a thermal therapy laser placement.It was reported that intra-operatively, the surgeon used the automated trajectory guidance unit and thermal therapy system drill guide set to drill a hole and the hole ended up larger than expected and the bone anchors would not fit the hole.They had to drill another hole using a shorter drill guide.The procedure was completed with a thirty minute delay.There was no reported impact to patient outcome.The surgeon suspected that it overbored the hole due to soft bone, the drill had to be pulsed in and out to make sure they didn't go too deep, and the surgeon alleged that the longer thermal therapy drill guide was less stable than the short drill guide.
Additional Manufacturer Narrative
H2) additional information: d11: lot number for product id: 28324 is 1148826.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: STEALTH AUTOGUIDE SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 10437081
• Report Number: 3007566237-2020-00358
• Device Sequence Number: 2743352
• Product Code: HAW
• UDI-Device Identifier: 00763000293659
• UDI-Public: 00763000293659
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191597
• 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
• Report Date (Section B): 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 29631
• Device Catalogue Number: 29631
• Device Lot Number: 0051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Weight: 82