FDA.reportPublic FDA data

MAUDE MDR 9688217

MDR report key
9688217
Report number
1723170-2020-00425
Event key
0
Event type
3
Date of event
2020-01-22
Date received
2020-02-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STACY RUEMPING
Address
7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CART 9733856 S7 STAFF ASSEMBLED 110VEAR, NOSE AND THROAT STEREOTAXIC INSTRUMENTMEDTRONIC NAVIGATION, INCPGW97338569733856Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-100

Event Narratives#

N

Patient 1

OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733467, SERIAL/LOT #: (B)(4). A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS REPORTED THAT THE HARDWARE AND SOFTWARE PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. PENDING SW ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM BECAME UNRESPONSIVE WHILE THE SURGEON WAS NAVIGATING DURING THE CASE. THE SYSTEM WAS REBOOTED AND THIS RESOLVED THE ISSUE. THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR. THERE IS NO KNOWN IMPACT ON PATIENT OUTCOME.