MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem Imprecision (1307)

Patient Problems Injury (2348); Iatrogenic Source (2498)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

No parts have been received by the manufacturer for evaluation.Part not returned for analysis.

Event Description

A medtronic representative reported that, while in a lead placement deep brain stimulation (dbs) procedure, an imprecision of 5mm was observed.The representative reported that an entry point was determined with a medtronic imaging system image acquisition.The burr hole and nexframe were then attached and a second imaging system image acquisition found that the plan and actual location varied.The entry point was reset and the navigation system displayed critical structures would be compromised.The surgeon indicated visually that no critical structures were present.The surgeon then placed the lead and a confirmation image acquisition found that the lead was placed 3mm parallel to the plan and recordings were not great.The surgeon then removed the lead, re-aligned to their target and performed a partial placement.Following partial placement, an image acquisition was performed to confirm trajectory.The lead was then placed and a confirmation image acquisition found accurate placement.No additional information was provided.

Manufacturer Narrative

Additional information: there was a reported delay to the procedure of thirty minutes due to this issue.

Manufacturer Narrative

The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 6966725
• MDR Text Key: 89919237
• Report Number: 1723170-2017-04277
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 76