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

Model Number S7

Device Problems Unintended Arm Motion (1033); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

Site neuro coordinator rn declined to provide patient information.Reported issue could not be replicated by the site nurse or by the medtronic representative.Site opted not to replace their articulating arm.No parts have been received by manufacturer for analysis.No further issues have been reported.Part not received by manufacturer.

Event Description

A medtronic representative reported a site navigation system articulating arm that moved during a cranial procedure.No further details regarding the behavior, or specifically when it occurred, were provided.Reported issue could not be replicated by the site nurse or by the medtronic representative.The surgeon opted to continue and completed the procedure with the use of the navigation system.Delay in therapy was 5 minutes.There was no impact on patient outcome.

• 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: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6331734
• MDR Text Key: 67493364
• Report Number: 1723170-2017-00747
• 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
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: No
• 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: 01/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2016
• 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