FDA.reportPublic FDA data

MAUDE MDR 6835396

MDR report key
6835396
Report number
1045254-2017-00299
Event key
0
Event type
3
Date of event
2017-08-07
Date received
2017-08-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SHARANYA JANGITI
Address
6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US
Phone
904-904-9043
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NIM? EMG ELECTRODEELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPHMEDTRONIC XOMED INC.IKT82274118227411J314645Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-310

Event Narratives#

N

Patient 1

ONE OPENED SAMPLE OF PART NUMBER 8227411, FROM LOT NUMBER J314645 WAS RECEIVED. THERE WAS A RESIDUE CONSISTENT WITH BIOLOGICAL CONTAMINANTS ON THE DEVICE. ONLY THE VIOLET ELECTRODE WAS RETURNED. VISUALLY, THERE WAS NO DAMAGE OR ANOMALIES IN THE CONSTRUCTION OF THE DEVICE THAT WOULD HAVE RESULTED IN THE REPORTED EVENT. THE PAIRED SUBDERMAL ELECTRODES SHALL EXHIBIT CONTINUITY FROM NEEDLE TIP TO CONNECTING PIN WITH A MEASUREMENT LESS THAN 2.0OHMS [AND SHALL EXHIBIT INFINITY BETWEEN NEEDLES AND CONNECTORS]; THE ACTUAL MEASUREMENT WAS 1.7OHMS / 1.7OHMS; THERE WAS AN INFINITE BETWEEN POLES AND NO OUT OF SPECIFICATION CONDITION WAS IDENTIFIED. THIS IS A SUPPLIED MATERIAL ASSEMBLY WITH NO OUT OF SPECIFICATION CONDITION THEREFORE MANUFACTURING AND SUPPLIER HAVE BEEN RULED OUT AS LIKELY CAUSES. THE INSTRUCTIONS FOR USE IDENTIFIES MULTIPLE REASONS FOR A REDUCED, IF NOT COMPLETELY ELIMINATE, EMG RESPONSES TO DIRECT OR PASSIVE NEURAL STIMULATION [AS A RESULT OF USE ERROR]. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

THE FACILITY REPORTED THAT THE WHEN THE DEVICE WAS STIMULATED, THERE WAS NO SENSING. THE NERVE LOCATION WAS KNOWN BUT THE DEVICE WAS NOT DETECTING THE NERVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SET OF ELECTRODES. THERE WAS NO PATIENT IMPACT.