FDA.reportPublic FDA data

MAUDE MDR 9581472

MDR report key
9581472
Report number
1644487-2020-00075
Event key
0
Event type
3
Date of event
2019-12-12
Date received
2020-01-13
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 106GENERATORCYBERONICS - HOUSTONMUZ106204717R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-1301. O

Event Narratives#

N

Patient 1

(B)(4).

D

Patient 1

IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED A FLUTTERING IN HER CHEST THAT STOPS WITH MAGNET DISABLEMENT. THE PATIENT STATED THAT THIS RESULTED IN ELEVATED BLOOD PRESSURE AND NOT SLEEPING WELL. THE PATIENT LATER CALLED AND DESCRIBED THE FLUTTERING AS ?AN ELECTRICAL CHARGE ENCAPSULATED IN HER CHEST.? THE PATIENT HAS BEEN FEELING NERVOUS AND AGITATED SINCE THE EVENT BEGAN. THE PATIENT ALSO STATED THAT SHE FELT FATIGUE AND HEAVINESS IN HER BODY UNTIL SHE MAGNET DISABLED THE VNS. THE PATIENT LATER REPORTED THAT SHE WAS FEELING FATIGUED AND EXPERIENCED NAUSEA SIMILAR IN THE PAST WHEN SHE HAD AN IMPLANTED DEVICE THAT CONTAINED NICKEL. THE VNS LEAD CONTAINS A NICKEL ALLOY, BUT THE ALLOY IS ENCASED IN SILICONE AND NOT IN CONTACT WITH THE BODY UNLESS THERE IS AN ISSUE. THE PATIENT STATED THAT AT THE LAST PHYSICIAN'S OFFICE VISIT, THE DIAGNOSTICS WERE "ALRIGHT". THE PATIENT STATED THAT HER VNS SETTINGS WERE LOWERED AT THAT TIME, BUT THE SIDE EFFECTS WERE STILL LINGERING. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.