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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II VENTRICULAR (ASSIST) BYPASS

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THORATEC CORPORATION HEARTMATE II VENTRICULAR (ASSIST) BYPASS Back to Search Results
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 12/17/2019
Event Type  malfunction  
Event Description
Patient with implanted heartmate ii left ventricular assist device (lvad) was admitted due to the second driveline fracture of 2nd heartmate ii lvad. Patient presented with lvad alarms. Waveforms were evaluated by abbott corp; short to shield occurring on grounded mobile power unit (mpu). X-rays did not reveal noticeable driveline fracture. Blind repair was not pursued at this time. Patient opted to pursue palliative management due to burden of other comorbidities including severe urinary retention/ bladder spasms/ failure to thrive with weight loss. Patient discharged home with battery power and ungrounded cable.
 
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Brand NameHEARTMATE II
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
MDR Report Key12518523
MDR Text Key272971041
Report Number12518523
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2021
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 FDA09/09/2021
Device Age3 YR
Event Location Home
Date Report to Manufacturer09/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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