MAUDE Adverse Event Report: ST. JUDE MEDICAL / ABBOTT HEARTMATE II - SVAD-20995; PUMP BLO VAD ASSIT LF

Model Number 10006662

Device Problems Device Issue (2379); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Death (1802)

Event Date 12/28/2020

Event Type  Death  

Event Description

Heartmate ii exchange.Device functioned correctly when tested prior to surgery, failed when attached and turned on.Pt expired.

• Brand Name: HEARTMATE II - SVAD-20995
• Type of Device: PUMP BLO VAD ASSIT LF
• Manufacturer (Section D): ST. JUDE MEDICAL / ABBOTT; plymouth MN
• MDR Report Key: 11245108
• MDR Text Key: 229335896
• Report Number: 11245108
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/20/2020,12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10006662
• Device Catalogue Number: 10006662
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2020
• Distributor Facility Aware Date: 12/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2020
• 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): Death
• Patient Age: 67 YR