MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC BIOPSY GUIDE; INSTRUMENT, STEREOTAXIC

Model Number 960-539

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 04/06/2020

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Device lot number, or serial number, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that, while outside of a procedure, the biopsy guide could not be locked into position.There was no patient present when this issue was identified.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: BIOPSY GUIDE
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9948472
• MDR Text Key: 187262017
• Report Number: 1723170-2020-01201
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K954276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 960-539
• Device Catalogue Number: 960-539
• Device Lot Number: 160707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1