MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 PREMIUM SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problem Imprecision (1307)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

Patient information was unavailable from the site.Udi not available for this system at time of filing.No parts have been received by the manufacturer for evaluation.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used for a catheter placement.It was reported that the surgeon alleged that the system was inaccurate inferior to both targets.After performing an auto registration with the imaging system, the site began navigating the procedure.It was not until the surgeon reached the target, that they alleged the inaccuracy.The site aborted navigation and never got the ablation using the thermal therapy system.There was a reported delay to the procedure of less than one hour due to this issue.The site checked the surface skin for accuracy after registration, but not after they draped.They never turned the laser on.

Manufacturer Narrative

Initial mdr inadvertently filed as only malfunction when it should have been filed as a serious injury due to the procedure being aborted.Initial reporter's name corrected.A medtronic representative went to the site to test the equipment.Testing revealed that the system was performing as intended.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received additional information that the laser induced thermal therapy (litt) procedure was aborted after the laser was placed but prior to any ablation.The patient was under anesthesia when the procedure was aborted and it was unknown if the patient was scheduled or rescheduled for any other procedure.

Manufacturer Narrative

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

• Brand Name: STEALTHSTATION S8 PREMIUM SYSTEM
• 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: 8031274
• MDR Text Key: 125911284
• Report Number: 1723170-2018-05455
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 11/01/2018; 02/13/2019
• Supplement Dates FDA Received: 12/01/2018; 02/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Weight: 60