FDA.reportPublic FDA data

MAUDE MDR 805532

MDR report key
805532
Report number
2916596-2007-00012
Event key
0
Event type
3
Date of event
2006-12-26
Date received
2007-01-02
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 DRIVE 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.DSQ12951295*K9200YNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-01-0201. R

Event Narratives#

D

Patient 1

THE PT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE PHYSICIAN THAT THE PT WAS ADMITTED TO THE HOSPITAL TWO DAYS PRIOR TO THE REPORTED EVENT AND PLACED ON PNEUMATIC SUPPORT USING STROKE VOLUME LIMITER (SVL) AND IP CONSOLE. THE PT WAS KNOWN TO POSSIBLY HAVE EXPERIENCED END OF LIFE PUMP SYMPTOMS. WHILE THE PT WAS ON PNEUMATIC SUPPORT, THE SVL DIAPHRAGM WOULD NOT MOVE AND STOPPED WORKING. THE PT WAS HAND PUMPED IMMEDIATELY, BUT NO RESISTANCE TO AIR FLOW WAS NOTICED AND THE SUBSEQUENT IMPLEMENTATION OF PNEUMATIC SUPPORT WITH THE IP CONSOLE WAS EFFECTIVE. A DECISION WAS MADE TO REPLACE THE LVAD WITH ANOTHER LVAD. SEE MDR 2916596-2007-00005 FOR FURTHER DETAILS ON LVAD ISSUES.

N

Patient 1

THE PT REMAINS ON LVAD SUPPORT. THE MFR WAS UNABLE TO PERFORM AN INVESTIGATION ON THE REPORTED EVENT; ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. THE DEVICE WAS DISCARDED BY THE CENTER AND THE LOT NUMBER OF THE DEVICE WAS NOT REPORTED TO THE MFR. THEREFORE, NO PHYSICAL TESTING OR DEVICE HISTORY RECORD REVIEW WAS POSSIBLE. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.