MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. AXIEM¿; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9734887XOM

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

Tracker would not register instrument when placed in divot to begin tracking.Would only register instrument when placed above divot, making tracking inaccurate.If the inaccurate tracking were used patient harm would have potentially taken place.

• Brand Name: AXIEM¿
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 16102442
• MDR Text Key: 306714953
• Report Number: 16102442
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00763000588380
• UDI-Public: (01)00763000588380(17)250727(10)2207281
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2022,11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9734887XOM
• Device Catalogue Number: 9734887XOM
• Device Lot Number: 2207281
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Sex: Female
• Patient Race: White