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

Model Number S7

Device Problems Material Frayed (1262); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern. Return requested. Replacement external axiem power/data cable shipped to site on (b)(6) 2016. Medtronic investigation of returned suspect external axiem power/data cable confirms the reported issue. Found communication cable for the axiem box is frayed and the wires are exposed. Cable was still fully functional, only the outer coax was damaged. Cable cut and damaged. Failure: physical damage. Hardware investigation was completed. This issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database. On 06/30/2016, a medtronic representative performed a navigation system check-out, software and instruments areas passed. Hardware test failed. Axiem power cable failed. Replaced cable. Issue resolved. System performed as intended. No further issues have been reported.

Event Description

A medtronic representative reported that a site's navigation system power and communication cable for the axiem box was frayed and the wires were exposed. No further details regarding the damage, or how it occurred, were provided. 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: 5806897
• MDR Text Key: 49954928
• Report Number: 1723170-2016-01422
• 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: 07/19/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse