MAUDE Adverse Event Report: ABBOTT HEARTMATE II; LVAD - LEFT VENTRICULAR ASSIST DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Seizures (2063)

Event Date 10/29/2020

Event Type  Injury  

Event Description

An (b)(6) y/o male with history of lvad hm2 in 2015 and exchange in 2016 presented to er with sustained witnessed seizure like episode that lasted about 5 mins.He presented to ed and was found to have an ich on ct scan.Pt awake and alert but has +pronator drift on arrival and no deficits currently.

• Brand Name: HEARTMATE II
• Type of Device: LVAD - LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): ABBOTT ; 6035 stoneridge dr.; pleasanton CA 94588
• MDR Report Key: 10945720
• MDR Text Key: 219530192
• Report Number: 10945720
• Device Sequence Number: 1
• Product Code: DSQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 10/30/2020,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2020
• Distributor Facility Aware Date: 10/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 68