FDA.reportPublic FDA data

MAUDE MDR 9908388

MDR report key
9908388
Report number
2916596-2020-01417
Event key
0
Event type
3
Date of event
2020-03-10
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. BOB FRYC
Address
6035 STONERIDGE DRIVE PLEASANTON CA 94588 US
Phone
781-781-7818
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)VENTRICULAR (ASSISST) BYPASSTHORATEC CORPORATIONDSQ106015106015R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. O

Event Narratives#

N

Patient 1

NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER?S INVESTIGATION IS COMPLETED.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT REDUCED ROTATIONS PER MINUTE (RPM) DUE TO VENTRICULAR TACHYCARDIA (VT). LOG FILE ANALYSIS SHOWED A NO EXTERNAL POWER EVENT DUE TO SIMULTANEOUS POWER LEAD DISCONNECTS WHILE THE PATIENT WAS SWITCHING POWER SOURCES. THERE WAS NO INTERRUPTION IN PUMP SUPPORT TO THE PATIENT DURING THIS EVENT. IT WAS LATER REPORTED THAT THE PATIENT WAS ON ORAL MEDICATION FOR VENTRICULAR TACHYCARDIA. ABLATION WAS ATTEMPTED IN THE PAST AND WAS UNSUCCESSFUL. THE PATIENT STATED HE ACCIDENTALLY DISCONNECTED BOTH POWER LEADS AT ONE TIME.