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

Model Number 9733858

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

Patient weight was unavailable from the site.The unique identifier was not none at the time of the event.Report source- foreign country: (b)(6).No parts have been received by the manufacturer for evaluation.(b)(4).The manufacture date was not known at the time of the event.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 procedure.It was reported that the patient was in the operating room and had undergone tracheal intubation combined with intravenous inhalation of general anesthesia with the fixed frame installed at the head.It was planned to perform the preoperative surgical plan and when the deep intracranial lead was placed the screen of the surgical navigation system appeared with a flash screen and then a black screen appeared.After rebooting the screen was still black and it was impossible to continue the operation plan.It was noted that there was a surgical bed failure.There was impact to the patient and the patient outcome was serious injury.Update from the manufacturer representative stating that this event was feedback by cfda not customer.All ae in china is not public information, we can¿t get further information due to government reason.

Manufacturer Narrative

Additional information was added to the event description.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received stating that the site stopped using it, and the device was repaired by the manufacturer representative.It was detected that it was the malfunction of the operation guide system circuit system and the motherboard failure.After maintenance the replaced the part the device could be normally used.The reported issue caused pain to the patient.

• 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: 8921616
• MDR Text Key: 155235440
• Report Number: 1723170-2019-04599
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733858
• Device Catalogue Number: 9733858
• Device Lot Number: 3220399
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 14 YR