MAUDE Adverse Event Report: MEDTRONIC, INC MEDTRONIC LVAD BATTERY; VENTRICULAR (ASSIST) BYPASS

Device Problems Failure to Power Up (1476); Battery Problem (2885); Charging Problem (2892)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2019

Event Type  Injury  

Event Description

Patient reports having problems with battery (#5/e).When charging at home, charger station has red light.Light moves with battery when changing port on battery charger.Battery does not charge and does not light up.Battery sn: (b)(4), manf.5/1/2018; supplied to patient (b)(6) 2018 after lube applied by medtronic rep.Battery removed from patient use during today's clinic visit.No charge warranty replacement requested from medtronic, battery will be returned to company for assessment.Patient sent home with new battery: (b)(4), manf 8/30/2018.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC LVAD BATTERY
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): MEDTRONIC, INC
• MDR Report Key: 8611944
• MDR Text Key: 145232609
• Report Number: MW5086626
• Device Sequence Number: 0
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2019
• 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: 77 YR
• Patient Weight: 99