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

Model Number 9733856

Device Problems Human-Device Interface Problem (2949); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Concomitant medical products: other relevant device(s) are: product id: 9680152, serial/lot #: unknown, ubd: 03-oct-2016.The manufacturer representative went to the site to test the navigation system.The reported issue was confirmed and parts were replaced.Eval code method 10 is associated with this analysis eval code result 114 is associated with this analysis eval code conclusion 4307 is associated with this analysis the bulkhead was returned to the manufacture for evaluation.After visual/physical examination the reported issue was confirmed.Both side walls of the returned connector are broken out with bent and broken contacts inside the connector.Mechanical damage was observed.Eval code method 10 is associated with this analysis eval code result 180 is associated with this analysis eval code conclusion 4307 is associated with this analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported outside of a procedure that the bulkhead was damaged on the system and they were unable to pull.No patient was present at the time of the event.Additional information received stating that the system was not able to pull from digital intercommunication of medicine (dicom) and electronic picture archiving and communication systems (pacs).The site had two other systems available, so they just used one of those instead of having radiology burn a disc.All other functions of the system performed as they should.

• Brand Name: S7
• 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: 9437633
• MDR Text Key: 183263237
• Report Number: 1723170-2019-05910
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2011
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Date Manufacturer Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2012
• 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