FDA.reportPublic FDA data

MAUDE MDR 7480523

MDR report key
7480523
Report number
2182208-2018-00827
Event key
0
Event type
3
Date of event
2018-04-04
Date received
2018-05-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ANNE SCHILLING
Address
8200 CORAL SEA ST NE MOUNDS VIEW MN 55112 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)MEDTRONIC, INC.DSA54875487Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-020

Event Narratives#

N

Patient 1

PRODUCT ANALYSIS: MANUFACTURER'S ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE CABLE WOULD NOT STAY CONNECTED. THE CABLE PASSED INCOMING TESTING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

IT WAS REPORTED THAT THE CABLE WOULD NOT STAY CONNECTED. THE CABLE WAS RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.