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

Device Problems Electrical /Electronic Property Problem (1198); Loose or Intermittent Connection (1371)

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

Event Date 02/17/2022

Event Type  Injury  

Event Description

Pt called on the evening of (b)(6) 2022 reporting that the connection where a battery attaches on her lvad was loose and had exposed wires.Pt reports that her equipment was in her bag all day and there had not been any known damage or pulls.Fda safety report id # (b)(4).

• Brand Name: HEARTWARE HVAD
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 13601656
• MDR Text Key: 286351679
• Report Number: MW5107711
• 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: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• 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
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White