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

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).

• Brand Name: MEDTRONIC HEARTWARE HVAD
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 13506658
• MDR Text Key: 285494130
• Report Number: MW5107367
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• 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 Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White