• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC LVAD; VENTRICULAR ASSIST

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

THORATEC LVAD; VENTRICULAR ASSIST Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908)
Event Date 05/27/2014
Event Type  Injury  
Event Description
Installing left ventricle assist device.Came undone and required a second surgery.To this day coping with high pressures in arteries and headaches.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LVAD
Type of Device
VENTRICULAR ASSIST
Manufacturer (Section D)
THORATEC
MDR Report Key6995776
MDR Text Key90933118
Report NumberMW5073081
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 Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age62 YR
Patient Weight104
-
-