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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEARTWARE LVAD CONTROLLER
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MEDTRONIC HEARTWARE LVAD CONTROLLER Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/23/2018
Event Type  malfunction  
Event Description
Patient called the heart and lung specialized care clinic to report multiple instances of power switching and beeping on his heartware lvad.He stated this is happening on multiple batteries.Clinic staff spoke with medtronic rep re: this and the decision was made for controller to be exchanged.Patient presented to have staff change controller.Old controller returned to medtronic per our protocol.
 
Manufacturer Narrative
The following elements have blank data.
 
Event Description
Patient called the heart and lung specialized care clinic to report multiple instances of power switching and beeping on his heartware lvad.He stated this is happening on multiple batteries.Clinic staff spoke with medtronic rep re: this and the decision was made for controller to be exchanged.Patient presented to have staff change controller.Old controller returned to medtronic per our protocol.
 
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Brand Name
HEARTWARE LVAD CONTROLLER
Type of Device
HEARTWARE LVAD CONTROLLER
Manufacturer (Section D)
MEDTRONIC
710 medtronic pkwy
minneapolis MN 55432
MDR Report Key7433315
MDR Text Key105588345
Report Number7433315
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 04/05/2018,04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2018
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/05/2018
Event Location Home
Date Report to Manufacturer04/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age50 YR
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