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

Model Number S7

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Unique device identification (udi) is unavailable.The battery was returned to the manufacturer for analysis.Analysis found that the battery would not charge at all and would shut down immediately under battery power with a load applied consisting of a 500w lamp.Analysis found that the reported event was related to an electrical issue.Device manufacturing date is unavailable.

Event Description

Medtronic received information regarding a navigation device.It was reported that the device was charged overnight but died immediately after being unplugged from the wall.This was observed outside of a surgical procedure.No impact on patient outcome.

Manufacturer Narrative

Correction: a medtronic representative went to the site to replace the battery and confirmed system was fully functional after replacement.The evaluation of the returned battery was previously reported on the initial mdr.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• 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: amos jarrette ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208903200
• MDR Report Key: 7604083
• MDR Text Key: 111146175
• Report Number: 1723170-2018-02664
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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