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 Patient Involvement (2645)

Event Date 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.On (b)(6) 2016 at the time the damaged was identified, a medtronic representative went to the site, tested the articulating arm and confirmed it was not tightening all the way.On (b)(6) 2016 a medtronic representative, following-up at the site, reported that the site biomed representative stated that their articulating arm was "fixed" and the site no longer wished to replace it.Suspect articulating arm will not be returned to manufacturer for analysis.Issue considered resolved by the site.No further issues have been reported.

Event Description

A medtronic representative reported a site articulating arm that was damaged.The site radiographic technologist (rt) identified the damage during surgical set-up.No further details regarding the damage, or how it occurred, were provided.The site used a second articulating arm to set-up for the upcoming procedure.A medtronic representative tested and confirmed the articulating arm was not tightening all the way.There was no patient present when this issue was identified.

• 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: 5865462
• MDR Text Key: 51882270
• Report Number: 1723170-2016-02066
• Device Sequence Number: 1
• Product Code: HAW
• 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: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2011
• 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