FDA.reportPublic FDA data

MAUDE MDR 9871433

MDR report key
9871433
Report number
3004785967-2020-00398
Event key
0
Event type
3
Date of event
2020-03-11
Date received
2020-03-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
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
1BASE SYS BI70002000 O-ARM SYS O2INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)OWBBI70002000BI70002000Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-240

Event Narratives#

N

Patient 1

NO PATIENT INVOLVED. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI71000452, SERIAL/LOT# UNKNOWN. ONSITE FUNCTIONAL AND VISUAL EXAMINATION WAS PERFORMED BY A MANUFACTURER REPRESENTATIVE. HARDWARE PARTS WERE REPLACED AND THE ISSUE WAS RESOLVED. THE SYSTEM PASSED A SYSTEM CHECKOUT AND WAS RETURNED TO AN OPERATIONAL CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SITE DAMAGED THEIR LOUVRE COVER. NO PATIENT PRESENT.