MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) BIOPSY NEEDLE KIT, PASSIVE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9733068

Device Problems Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

Patient weight not made available from the site.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.In trouble-shooting, the medtronic representative performed the registration and planning with biopsy needle.The biopsy needle was detected and navigation system found to be working normally.On 11/08/2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.Return requested.Replacement passive biopsy needle shipped to site 11/08/2016.Medtronic investigation of returned suspect device finds the passive biopsy needle to be in good condition with no apparent physical damage and were able to track without issue.No problem found.

Event Description

A medtronic representative reported that, while in a cranial biopsy procedure, the biopsy needle could not be detected by the navigation system camera.Every other device was being detected.Surgeon tried cleaning the spheres and opened a new needle with a different lot number.The camera would still not detect the needle.The biopsy procedure was selected on the navigation system.The surgeon proceeded to take a biopsy with the needle.The surgeon knew the distance to target and just set the stop on the needle to this measurement and proceeded to take a biopsy without navigation.The surgeon opted to continue and completed the procedure without the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.

• Brand Name: BIOPSY NEEDLE KIT, PASSIVE
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6139147
• MDR Text Key: 61313509
• Report Number: 1723170-2016-05617
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169702943
• UDI-Public: 00643169702943
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K971247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/01/2016

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: Physician
• Device Catalogue Number: 9733068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: (B)(4)
• Patient Age: 33 YR