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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3; LEFT VENTRICULAR ASSIST DEVICE

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THORATEC CORPORATION HEARTMATE 3; LEFT VENTRICULAR ASSIST DEVICE Back to Search Results
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2020
Event Type  Injury  
Event Description
On (b)(6) 2020 new backup controller issued due to damage to black battery cable.
 
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Brand Name
HEARTMATE 3
Type of Device
LEFT VENTRICULAR ASSIST DEVICE
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge dr.
pleasanton CA 94588
MDR Report Key15105271
MDR Text Key296651534
Report Number15105271
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 Nurse
Type of Report Initial
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/25/2022
Distributor Facility Aware Date12/18/2020
Device Age6 MO
Date Report to Manufacturer07/25/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/25/2022
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient SexMale
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