MAUDE Adverse Event Report: MEDTRONIC/HEARTWARE HEARTWARE HVAD

Model Number 1403US

Device Problems Loose or Intermittent Connection (1371); Device Issue (2379); No Fail-Safe Mechanism (2990)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Loss of consciousness (2418)

Event Date 10/22/2016

Event Type  Death  

Event Description

On (b)(6) 2016 at 1453, pt's son-in-law called mcs coordinator on call stating the pt was found dead, ems and coroner on scene to pronounce pt.Pt's son-in-law was calling mcs coordinator to ask what to do about the pump because the pt was laying on the pump and it was not alarming.Mcs coordinator spoke with local pa who was also on scene with pt and family.Instructed pt's son on how to disconnect controller from pt's driveline so that it can be sent to (b)(6) to be interrogated.Controller removed from pt by son without difficulty and given to sheriff's office until investigation is completed.Pa stated she would get all the details of incident and contact mcs coordinator when completing her report.On (b)(6) 2016 at 1556, pa called mcs coordinator and described timeline of events: (b)(6) - pt c/o bug bite that had been bothering him to family; (b)(6) 1400: pt not feeling great, goes to take a nap, he lives lone but his sister and her husband are staying on his property in motor home.Pt asks sister to wake him up at 1500, they have plans this afternoon; (b)(6) 1445: pt's sister goes into house, pt is still in bed; (b)(6) 1500: pt's brother-in-law goes into house and finds pt dead in hallway, face down with "blood everywhere." nothing on hvad lvad is alarming.Pa states that pt's family stated it looked to them like he was heading toward battery charger where he would normally go if he was changing his hvad battery.Pt was found with no power to hvad lvad and no alarm sounding, with one battery with one yellow bar and under him and one battery fully charged near by.Local pa was given pt's primary controller and this will be sent to (b)(6) for interrogation, released by sheriffs dept into her possession as there was determined to be no foul play around situation.

• Brand Name: HEARTWARE HVAD
• Type of Device: HVAD
• Manufacturer (Section D): MEDTRONIC/HEARTWARE; framingham MA
• MDR Report Key: 6107050
• MDR Text Key: 60309168
• Report Number: 6107050
• 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: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1403US
• 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: 11/04/2016
• Distributor Facility Aware Date: 10/22/2016
• Device Age: 6 YR
• Event Location: Home
• Date Report to Manufacturer: 11/04/2016
• 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: 72 YR
• Patient Weight: 62