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

Model Number S7 PLANNING STATION

Device Problems Device Emits Odor (1425); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 04/11/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Return requested for suspect monitor 04/12/2017.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A medtronic representative reported that a site's planning station monitor was smoking.Hit was stated that before fully inserting the cord prongs into the outlet, it passed an electric arc between the prongs and outlet.The medtronic representative pulled the cable away and then the monitor started smoking.In trouble-shooting, the medtronic representative attempted to plug the monitor into a different outlet, however, the issue persisted.A replacement monitor at the site was utilized, it worked fine and there were no further issues.No further details regarding the behavior, or specifically when it occurred, were provided.There was no impact on patient outcome.

Manufacturer Narrative

The suspect monitor was returned to the manufacturer for evaluation.A power connector within the monitor was found to have shorted.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: STEALTHSTATION S7 PLANNING STATION
• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6559173
• MDR Text Key: 74903309
• Report Number: 1723170-2017-01821
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994532398
• UDI-Public: 00613994532398
• 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
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S7 PLANNING STATION
• Device Catalogue Number: 9734048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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