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

Model Number S7

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

On 12/21/2016 software investigation completed.Findings confirmed that the image did not meet stealth protocol; space and thickness 2.5 millimeters.Attempted tracer registration and 3 point registration.Tracer failed 3 times, however 3 point passed.Concluded the image not meeting protocol likely caused difficulty registering patient.- no system evaluation required as resolution was confirmed at the time of the call to medtronic technical services.- no parts have been received by manufacturer for analysis.- no further issues have been reported.

Event Description

A medtronic representative reported that, while in an ear, nose & throat (ent) procedure, the navigation system image was not up to protocol.Axial but 2.5 millimeters for thickness and spacing.Image was loaded, however, could not pass the registration.Tracer and 3 point registration were performed multiple times, without success.The surgeon opted to discontinue the use of the navigation system and after less than an hour delay, abandoned the surgery.There was no impact on patient outcome.

Manufacturer Narrative

Additional information: the instructions for use (ifu) which accompanies the device contains guidance and instructions regarding proper imaging protocols for cranial, dbs, spine, and ent applications.

Manufacturer Narrative

After additional review of this event it has been identified that this event meets the definition of a serious injury.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S7 SYSTEM
• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6195760
• MDR Text Key: 63081354
• Report Number: 1723170-2016-05778
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2014
• 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: 66 YR
• Patient Weight: 83