MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC 2 COIL STYLET; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9735428

Device Problem Biocompatibility (2886)

Patient Problem Unspecified Infection (1930)

Event Date 10/22/2021

Event Type  Injury  

Manufacturer Narrative

Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used during a procedure.It was reported that an infection occurred during the procedure utilizing the navigation stylet.There was no reported delay to the procedure due to this issue.

• Brand Name: 2 COIL STYLET
• 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: 12814769
• MDR Text Key: 280789373
• Report Number: 1723170-2021-02694
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169490468
• UDI-Public: 00643169490468
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K141833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 9735428
• Device Catalogue Number: 9735428
• Device Lot Number: 210430A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2021
• 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
• Patient Outcome(s): Required Intervention