FDA.reportPublic FDA data

MAUDE MDR 9862993

MDR report key
9862993
Report number
1644487-2020-00476
Event key
0
Event type
3
Date of event
2020-02-18
Date received
2020-03-20
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
MRS. RACHEL KOHN
Address
100 CYBERONICS BLVD SUITE 600 HOUSTON TX 77058 US
Phone
281-281-2812
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PULSE GEN MODEL 1000GENERATORCYBERONICS - HOUSTONLYJ1000204553R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-200

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS ABLE TO BE INTERROGATED BUT WAS NOT ABLE TO HAVE THE SETTINGS CHANGED, A COMMUNICATION ERROR MESSAGE WAS RECEIVED. INFORMATION WAS LATER RECEIVED THAT WHEN THE VNS WAS ATTEMPTED TO BE PROGRAMMED OR A SYSTEM DIAGNOSTICS WAS ATTEMPTED, ERROR CODE 254 WAS SEEN. TWO DIFFERENT PROGRAMMING SYSTEMS WERE USED AND THE ERROR WAS SEEN ON BOTH. A GENERATOR RESET WAS PERFORMED AND FOLLOWING THE RESET, A DISABLED MESSAGE WAS SEEN ALONG WITH LOW IMPEDANCE. THE ERROR CODE MESSAGES, DISABLED MESSAGE AND LOW IMPEDANCE AFTER RESET CAN BE ASSOCIATED WITH A REED SWITCH FAILURE. REVIEW OF THE INTERNAL DATA OF THE GENERATOR INDICATED THAT THE RUN STATE OF THE DEVICE ON WAS "STIM INHIBITED" WHICH CAN BE RELATED TO A STUCK REED SWITCH. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.