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

Model Number 9733857

Device Problems Human-Device Interface Problem (2949); Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative visited the site and completed a system checkout.The camera cable was replaced and the system performed as intended.The cable was discarded and not returned for analysis.The device manufacture date is 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 outside a procedure.It was reported that there was a broken pin on the camera cable.It was reported that the cable damage prevented camera communication.There was no patient present when this issue was identified.

• Brand Name: STEALTHSTATION® 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: 8469216
• MDR Text Key: 140452442
• Report Number: 1723170-2019-01460
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450951
• UDI-Public: 00613994450951
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733857
• Device Catalogue Number: 9733857
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2018
• 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