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

Model Number S7

Device Problems Communication or Transmission Problem (2896); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2014

Event Type  malfunction  

Manufacturer Narrative

The actual patient weight was (b)(6) which was rounded up to (b)(6) in the field due to character limitations.

Event Description

A medtronic representative reported that during a spinal fusion procedure, the o-arm 1000 imaging system exam could not be transferred to the stealthstation s7 system.In trouble-shooting, several attempts to manually send o-arm exam to the stealth were completed, after which the exam was successfully sent.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Patient weight not made available from the site.A medtronic representative, following-up at the site, reported they could not establish communication until the entire system was re-booted.Re-starting via exiting the admin desktop did not help establish communication.- software investigation completed.Findings are that after the system update, the system was reconfigured but not re-booted.Once reboot happened, the images were sent successfully and no further issues.Software is functioning as designed.Not a failure.(b)(4) 2014 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.Upgraded fusion ent 2.3 software.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 4195973
• MDR Text Key: 12577433
• Report Number: 1723170-2014-01120
• 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: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 09/23/2014

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: Medical Equipment Company Technician/Representative
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/23/2014
• Initial Date FDA Received: 10/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2013
• 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 Age: 65 YR
• Patient Weight: 77