MAUDE MDR 2136542

MDR report key
2136542
Report number
3007625360-2007-00001
Event key
0
Event type
3
Date of event
2007-08-07
Date received
2007-08-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
2203 NE OREGON STREET PORTLAND OR 97232 US
Phone
503-503-5032
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EPLEY OMNIAXNONEVESTICON, INC.LXVB5NANAN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-08-1601. H

Event Narratives#

D

Patient 1

A (B)(6), FEMALE, WITH RECURRENCE OF BPPV UNDERWENT RIGHT POSTERIOR CANAL REPOSITIONING ON THE OMNIAX USING A "LI" VIBRATOR. THE PT HAD MILD SYMPTOMS OF VERTIGO AND MILD NAUSEA DURING THE REPOSITIONING. NYSTAGMUS HAD RESOLVED AFTER THE MANEUVER. THE PT WAS ALLOWED TO SIT WITH THE VIBRATOR FOR AN ADDITIONAL 6 MINUTES IN THE UPRIGHT POSITION. WHEN RETURNING TO REMOVE HER FROM THE CHAIR, SHE NOTED ONSET OF RIGHT UPPER CHEST PAIN/DISCOMFORT. SHE WAS COLD, CLAMMY AND DIAPHORETIC WITH A NORMAL PULSE. SHE HAD UNLABORED BREATHING AND APPEARED TO BE CONCERNED BUT NOT DISTRESSED. AFTER LETTING HER REST FOR 10-15 MINUTES, HER SYMPTOMS HAD NOT CHANGED SO WE PUT HER IN A WHEELCHAIR AND BROUGHT HER TO THE ER. INITIAL EKG AT THE ER SHOWED NON-SPECIFIC CHANGES AND SECOND EKG A COUPLE HOURS LATER WAS NORMAL. CHEST PAIN RESOLVED SHORTLY AFTER ARRIVAL TO THE ER. TROPONIN LEVEL CAME BACK ELEVATED. ECHO WAS NORMAL. ANGIOGRAM PERFORMED THE NEXT DAY WAS NORMAL AND PT WAS DISCHARGED HOME. CARDIOLOGIST STATED THERE WAS NO MYOCARDIAL INFARCTION AND WAS UNCERTAIN AS TO WHAT HAPPENED.

N

Patient 1

.