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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 Problems Break (1069); Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 04/13/2021
Event Type  Injury  
Event Description
Upon admission (b)(6) 2021 it was noted that patient had 3 tears to his driveline, each measuring less than 1 cm. No visible internal wires damaged. Rescue tape applied to affected areas.
 
Event Description
Upon admission (b)(6) 2021 it was noted that patient had 3 tears to his driveline, each measuring less than 1 cm. No visible internal wires damaged. Rescue tape applied to affected areas.
 
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Brand NameHEARTMATE II
Type of DeviceLEFT VENTRICULAR ASSIST DEVICE
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge dr.
pleasanton CA 94588
MDR Report Key13585713
MDR Text Key286082076
Report Number13585713
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 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2022
Is this an Adverse Event Report? No
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 FDA02/11/2022
Distributor Facility Aware Date04/13/2021
Device Age5 YR
Event Location Home
Date Report to Manufacturer02/11/2022

Patient Treatment Data
Date Received: 02/14/2022 Patient Sequence Number: 1
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