FDA.reportPublic FDA data

MAUDE MDR 664302

MDR report key
664302
Report number
2023988-2005-00044
Event key
0
Event type
3
Date received
2005-09-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
LINDA GOODSTEIN
Address
311C ENTERPRISE DRIVE PLAINSBORO NJ 08536 US
Phone
609-609-6099
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XLNEUROSENSORINTEGRA NEUROSCIENCESDPW*NS-PW050708NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-09-150

Event Narratives#

D

Patient 1

THREE INCIDENTS WERE REPORTED BY THIS USER FACILITY. WHILE ZEROING THE ICP PORTION OF THE PROBE, A SIGNIFICANT DIFFERENCE BETWEEN THE PROBE READINGS IN THE VIAL AND THE PROBE READINGS OUTSIDE THE VIAL WERE OBSERVED. ALSO MENTIONED WERE BIG DIFFERENCES BETWEEN CBF MEASUREMENTS FROM THE GREY TO WHITE MATTER. THE PHYSICIAN EXPRESSED A GREATER CONCERN WITH THE DIFFERENCE IN THE ICP MEASUREMENTS THAN WITH THE CBF MEASUREMENTS. THIS MEDICAL REPORT IS LINKED TO MEDICAL DEVICE REPORT 2023988-2005-00042 AND #2023988-2005-00045.