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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC HEARTWARE HVAD VENTRICULAR (ASSIST) BYPASS

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MEDTRONIC, INC. MEDTRONIC HEARTWARE HVAD VENTRICULAR (ASSIST) BYPASS Back to Search Results
Device Problems Use of Device Problem (1670); Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 01/28/2022
Event Type  Injury  
Event Description
Pt phoned lvad urgent hotline reporting controller fault alarm on hvad lvad controller. The lvad flow was not interrupted and pt was transported via private vehicle to uch ed for controller exchange with lvad rn. Controller exchanged in ed without incident, pt tolerated well. Fda safety report id # (b)(4).
 
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Brand NameMEDTRONIC HEARTWARE HVAD
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key13506658
MDR Text Key285494130
Report NumberMW5107367
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
Type of Report Initial
Report Date 02/08/2022
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? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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