MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC AXIEM¿ CRANIAL NON-INVASIVE SHUNT KIT; INSTRUMENT, STEREOTAXIC

Model Number 9733605

Device Problem Device Unsafe to Use in Environment (2918)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

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 system.It was reported that there was a hair in the sterile package of the axiem shunt kit.This was found before it was opened up.A new one was pulled and used without incident.There was no patient involvement and no delay of the case.

Manufacturer Narrative

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

Manufacturer Narrative

The component was returned for analysis.Visual/physical examination of the returned shunt kit confirmed the reported issue.The returned kit had a hair inside the sealed package.This issue has been documented in a hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIEM¿ CRANIAL NON-INVASIVE SHUNT KIT
• 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: 8603627
• MDR Text Key: 144825754
• Report Number: 1723170-2019-02301
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169425019
• UDI-Public: 00643169425019
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2020
• Device Model Number: 9733605
• Device Catalogue Number: 9733605
• Device Lot Number: 180821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Date Manufacturer Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2018
• 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