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

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2021

Event Type  Injury  

Event Description

Patient c/o battery not charging.Battery "never gets above 2 bars." patient states that he has tried charging in different ports on his battery charger, and other batteries charge to capacity, but this one does not.Sn of battery taken out of service: (b)(4), sn of battery issued today: (b)(4).Fda safety report id # (b)(4).

• Brand Name: HEARTWARE HVAD LVAD
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 11975421
• MDR Text Key: 255657392
• Report Number: MW5101799
• Device Sequence Number: 1
• Product Code: DSQ
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR