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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

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THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE Back to Search Results
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 04/03/2019
Event Type  Injury  
Event Description
On (b)(6) 2019 patient in clinic with noted tear to driveline. Rescue tape applied.
 
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Brand NameHEARTMATE II
Type of DeviceLEFT VENTRICULAR ASSIST DEVICE
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
MDR Report Key15105159
MDR Text Key296651449
Report Number15105159
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/21/2022
Distributor Facility Aware Date06/08/2021
Device Age3 YR
Event Location Home
Date Report to Manufacturer07/21/2022

Patient Treatment Data
Date Received: 07/22/2022 Patient Sequence Number: 1
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