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

Model Number S7

Device Problems Imprecision (1307); Device Operates Differently Than Expected (2913)

Patient Problems Brain Injury (2219); Therapeutic Response, Decreased (2271); Iatrogenic Source (2498)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(4) 2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.On (b)(4) 2016 a medtronic representative, following-up at the site, reported navigation was used for the second procedure and the surgeon deemed everything was placed correctly.Reports to date tell us that the catheter was successfully placed and there have been no additional revisions scheduled for this procedure on this patient.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A medtronic representative reported that the surgeon had set-up a plan for a cranial shunt guided by axiem.The surgeon performed the procedure, however, alleged having difficulty hitting the planned target, a 9 millimeter sized ventricle, using navigation.The surgeon chose to try "going in blind" and was successful hitting the desired target.Revision procedure scheduled for (b)(6) 2016, 2 days later, due to less than ideal placement of catheter.Delay in therapy was less than one hour.

Manufacturer Narrative

A review of the software scans from the incident found that they appeared to follow the imaging protocol.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 and the behavior was not reproducible.

Manufacturer Narrative

Additional information: a medtronic representative reported that the imprecision was estimated to be 3 millimeters.

• 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 ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6087715
• MDR Text Key: 59452103
• Report Number: 1723170-2016-02873
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2017

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
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/05/2016; 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2012
• 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: 24 YR
• Patient Weight: 59