FDA.reportPublic FDA data

MAUDE MDR 9880048

MDR report key
9880048
Report number
3002953813-2020-00013
Event key
0
Event type
3
Date of event
2020-03-11
Date received
2020-03-25
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
STEPHANIE O' SULLIVAN
Address
5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US
Phone
651-651-6517
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NEUROTHERM? ADAPTOR CABLE NT GENERATOR TO DISPOSABLEMEDICAL DEVICE ELECTRICAL CABLE, REUSABLENEUROTHERM, INCIKDDACUK-NTR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2501. O

Event Narratives#

N

Patient 1

THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. DEVICE RETURN WAS REQUESTED HOWEVER THE ADAPTOR CABLE WAS RETAINED BY THE CUSTOMER. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE BATCH NUMBER WAS NOT AVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED COMMUNICATION ISSUE AND SUBSEQUENT CANCELLED PROCEDURE COULD NOT BE DETERMINED.

D

Patient 1

DURING A RADIOFREQUENCY (RF) ABLATION PROCEDURE A CANCELLATION OCCURRED DUE TO A COMMUNICATION ISSUE. FOLLOWING PATIENT PREP, WHEN RF PROBES WERE CONNECTED TO THE GENERATOR THE INDICATOR LIGHT REMAINED RED. DIFFERENT PROBES AND ADAPTORS WERE UTILIZED AND THE GENERATOR WAS RESTARTED BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.