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

Model Number S7

Device Problems Unintended Arm Motion (1033); Material Integrity Problem (2978); Unintended Movement (3026)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.

Event Description

A medtronic representative reported that while outside of procedure, the vertek arm was not locking down.There was no patient present at the time of the issue.

Manufacturer Narrative

Fda codes were updated to reflect current coding.If information is provided in the future, a supplemental report will be issued.

• 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: prashanth gali ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7151470
• MDR Text Key: 96013665
• Report Number: 1723170-2017-05344
• 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: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733927
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2011
• 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