MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9733927

Device Problem Human-Device Interface Problem (2949)

Patient Problems Tissue Damage (2104); Iatrogenic Source (2498)

Event Date 06/18/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 9735585, serial/lot #: unknown.Device udi number unavailable.No hardware parts have been returned to the manufacturer for analysis.Device manufacturing date unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a cranial biopsy procedure.It was noted that the surgeon was a first-time user of the navigation system, and it was noted that an articulating arm was being used as well.It was reported that after several registrations the surgeon kept stating that she was inaccurate.The surgeon did not state in which direction, but she did state that she felt 4mm off after checking known landmarks.The surgeon then chose to abort the surgery.The surgery had been started and anesthesia had been administered at the time the surgery was aborted.Additionally, a skin incision was made prior to the surgery being aborted.There was conflicting information presented, however, that an incision had not been made.There was a surgical delay of less than 1 hour due to this issue.The surgery was rescheduled for a later date; it was noted that they used a medtronic navigation system with a frame for coordinates, and it was noted that the case went well.For the original case, there were no reported symptoms caused by navigation that a medtronic representative was made aware of.The only impact on the patient was the need to reschedule the surgery and go under anesthesia again.

Manufacturer Narrative

Other relevant device(s) are: product id: 9735585 (software version: 3.1.1).Device evaluation: a software analysis was completed but was unable to determine probable cause without further information since the behavior cannot be replicated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information and clarification was received.The registration was done multiple times.The surgeon thought her final registration was adequate.A skin incision was made.She double checked accuracy and then decided that she didn¿t think it was accurate enough.The skin incision was made, but not into the skull bone.

• Brand Name: STEALTHSTATION S7 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: 8800969
• MDR Text Key: 151403331
• Report Number: 1723170-2019-04118
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• 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
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733927
• Device Catalogue Number: 9733927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 91