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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE LEFT VENTRICULAR ASSIST DEVICE

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HEARTWARE LEFT VENTRICULAR ASSIST DEVICE Back to Search Results
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 01/16/2021
Event Type  Injury  
Event Description
On (b)(6) 2021 patient with heartware driveline with multiple fractures. Heartware replaced with heartmate iii.
 
Event Description
On (b)(6) 2021 patient with heartware driveline with multiple fractures. Heartware replaced with heartmate iii.
 
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Brand NameHEARTWARE
Type of DeviceLEFT VENTRICULAR ASSIST DEVICE
MDR Report Key13585632
MDR Text Key286063010
Report Number13585632
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 03/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/02/2021
Distributor Facility Aware Date01/16/2021
Device Age90 MO
Event Location Home
Date Report to Manufacturer11/02/2021

Patient Treatment Data
Date Received: 02/09/2022 Patient Sequence Number: 1
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