MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) ARM RADIOLUCENT FRAME MOUNT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9734921

Device Problems Unintended Arm Motion (1033); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

No parts have been received by manufacturer for evaluation.Part not returned for evaluation.

Event Description

A medtronic representative reported that during a monteris procedure, a screw attaching the reference frame to navigation system was stripped.Site used another reference frame to complete the procedure.The procedure was completed with the use of navigation.There was a delay of less than 10 minutes.No impact on patient outcome.

• Brand Name: ARM RADIOLUCENT FRAME MOUNT
• 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: 6890518
• MDR Text Key: 87222795
• Report Number: 1723170-2017-03884
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9734921
• Device Lot Number: 141101
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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
• Patient Age: 71 YR
• Patient Weight: 84