MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) BIOPSY GUIDE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 960-539

Device Problems Unstable (1667); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not made available from the site.Device lot number, or serial number, not available.Mfg date: device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.Part not received by manufacturer.

Event Description

A medtronic ent representative received a report from the site that, while in a cranial procedure, their biopsy guide was damaged.The surgeon was using a wench to try and tighten and lock the position, however, it was still too loose.No further details regarding the damage, or how it occurred, were provided.The surgeon opted to continue and completed the procedure with the use of the navigation system.There was no delay of therapy reported.There was no impact on patient outcome.

Manufacturer Narrative

Correction: a medtronic representative, following up with the site, reported that the procedure was completed on (b)(6) 2016 and the medtronic representative was not notified of the event until 30-mar-2016.Event date now corrected.

• Brand Name: BIOPSY GUIDE
• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 5602228
• MDR Text Key: 43481399
• Report Number: 1723170-2016-00619
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954276
• 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: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 960-539
• Device Lot Number: 140505
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2014
• 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