FDA.reportPublic FDA data

MAUDE MDR 9554215

MDR report key
9554215
Report number
1644487-2020-00045
Event key
0
Event type
3
Date of event
2019-12-02
Date received
2020-01-06
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
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 106GENERATORCYBERONICS - HOUSTONMUZ106204783R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-0601. H

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SWELLING AT THE NECK INCISION SITE. IT WAS STATED THAT THE SURGEON BELIEVED IT TO BE A HEMATOMA AND THAT THE PATIENT WAS TO SEE THE SURGEON. FOLLOW UP WITH THE PHYSICIAN'S OFFICE REVEALED THAT THE HEMATOMA WAS THE PATIENT'S ASSESSMENT AND NOT THE MEDICAL PROFESSIONAL'S. THE SURGEON'S NURSE STATED THAT THE SWELLING WAS RELATED TO BLOOD CLOTS/THE PATIENT'S BLOOD THINNING MEDICATION BEING TAKEN FOR A WEEK PRIOR TO THE PATIENT BEING INSTRUCTED TO CONTINUE WITH THE MEDICATION. THE PATIENT WAS HOSPITALIZED FOR A FEW DAYS AND IT WAS STATED THAT THIS WAS TO PRECLUDE A SERIOUS INJURY. THE EVENT WAS ATTRIBUTED TO THE PATIENT'S BLOOD CLOTS AND THE PATIENT'S BLOOD THINNING MEDICATION BEING TAKEN PREMATURELY. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.