MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC N/A; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 960-521

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the depth guide slipped and the drill went deeper than expected.There was no patient present.

• Brand Name: N/A
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12590337
• MDR Text Key: 275176787
• Report Number: 1723170-2021-02451
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00673978089904
• UDI-Public: 00673978089904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 960-521
• Device Catalogue Number: 960-521
• Device Lot Number: 170327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/07/2021
• Date Device Manufactured: 03/27/2017
• 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