FDA.reportPublic FDA data

MAUDE MDR 800284

MDR report key
800284
Report number
2916596-2006-00215
Event key
0
Event type
3
Date of event
2006-12-01
Date received
2006-12-14
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
ROBERT FRYC
Address
6035 STONERIDGE DR PLEASANTON CA 94588 US
Phone
925-925-9258
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HEARTMATE STROKE VOLUME LIMITERSTROKE VOLUME LIMITERTHORATEC CORP.DSQ12951295NAK9200YNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-12-1401. R

Event Narratives#

D

Patient 1

THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY VAD SUPPORT THAT THE PT HAD BEEN PLACED ON BACK UP PNEUMATIC SUPPORT USING STROKE VOLUME LIMITER (SVL) AND IP CONSOLE FOR 1 WEEK PRIOR TO THIS REPORTED EVENT. WHILE ON BACK UP PNEUMATIC SUPPORT, AN AUDIBLE AIR LEAK CONTINUED TO BE NOTED AT THE VENT ADAPTER OF THE SVL. IT WAS REPORTED THAT THE AIR LEAK IS POSITIONAL AND NOT CONSTANT AS IF THE LEAK INVOLVED THE BLUE O-RINGS BENEATH THE VENT ADAPTER. THE USER FACILITY CHOSE NOT TO REPLACE THE BLUE O-RINGS AT THE TIME OF THE EVENT AND IS VENTING THE IP CONSOLE EVERY HOUR.

N

Patient 1

THE PT REMAINS STABLE ON BACK UP PNEUMATIC SUPPORT AND HAS BECOME A HEART TRANSPLANT CANDIDATE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.