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 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

Return requested.Replacement articulating arm shipped to site 08/12/2016.No parts have been received by manufacturer for analysis.On 08/16/2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.

Event Description

A site representative reported a site navigation system articulating arm that would not tighten properly.No further details regarding the damage, or how it occurred, were provided.There was no patient present when this issue was identified.

Manufacturer Narrative

The suspect vertek arm was returned to the manufacturer for evaluation.Testing found that the arm failed force testing by only withstanding 3.7 pounds of force downwards and sideways.With the standards for passing being 14 pounds and 10 pounds respectively.Visual inspection found wear and tear on the vertek arm from use and age of the instrument.This indicated a mechanical failure due to the force testing failure.

• 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 ; 7208902187
• MDR Report Key: 5929776
• MDR Text Key: 53954212
• Report Number: 1723170-2016-02143
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• 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: 9733858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2012
• 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