FDA.reportPublic FDA data

MAUDE MDR 594794

MDR report key
594794
Report number
MW4003903
Event key
0
Event type
3
Date received
2005-04-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DIGITAL ANGEL**NRV***Y*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-04-070

Event Narratives#

D

Patient 1

EACH SIGNAL SCAN CAN IRRITATE NERVES ADJACENT TO THE CHIP. THIS CAN CAUSE PAIN AND MAY ALSO MAKE NORMAL SLEEP IMPOSSIBLE.