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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP VENTRICULAR (ASSIST) BYPASS

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THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 104911JPN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Pleural Effusion (2010); Hemorrhagic Stroke (4417)
Event Date 02/03/2020
Event Type  Injury  
Event Description
It was reported that the patient was admitted on (b)(6) 2020 for pleural effusion. On (b)(6) 2020 the patient experienced neurological dysfunction (intracranial bleed in the left hemisphere).
 
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.  .
 
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Brand NameHEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key13384918
MDR Text Key286963188
Report Number2916596-2022-00541
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P060040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2020
Device Model Number104911JPN
Device Lot Number5952758
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/28/2022 Patient Sequence Number: 1
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