MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL; SIMILAR DEVICE: NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was denied by the site.No 510(k) provided as this device is not released for distribution in the united states.No parts have been returned to the manufacturer for analysis.Manufacture date is unavailable.

Event Description

Medtronic received information that, while using the navigation system for a cranial resection case, the system was turned on, the image on the upper half of the monitor was distorted and the lower half of the monitor was pitch-dark.The system was restarted, resolving the issue.There was no reported delay to the procedure due to this issue.

Manufacturer Narrative

Manufacture date.

• Brand Name: CART 9734056 S7 STAFF SHRT 100-120V INTL
• Type of Device: SIMILAR 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: erika mitchellette ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7874801
• MDR Text Key: 120245226
• Report Number: 1723170-2018-04622
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• 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: 9734056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2015
• 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