FDA Adverse Event Death Summary report: N

MEDTRONIC HEARTWARE LVAD

MDR report key: 12632772 · Received September 29, 2021

Report

Report Number
12632772
Event Type
Death
Date Received
September 29, 2021
Date of Event
August 27, 2021
Report Date
September 23, 2021
Manufacturer
MEDTRONIC
Product Code
DSQ
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
PA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

A (B)(6) Y/O MALE WITH PAST MED HISTORY SIGNIFICANT FOR ISCHEMIC CARDIOMYOPATHY, HEART FAILURE AND INSERTION OF A LEFT VENTRICULAR ASSIST DEVICE (LVAD) IN 2019. HE WAS ADMITTED ON (B)(6) 2021 AFTER HIS ICD FIRED APPROPRIATELY FOR VF/VT. AN ECHO SHOWED WORSENING RV DYSFUNCTION. NEPHROLOGY WAS CONSULTED DUE TO SIGNIFICANT HYPONATREMIA AND ELECTROPHYSIOLOGY WAS TREATING HIM MEDICALLY FOR VF/VT. THE PLAN WAS FOR HEART CATHETERIZATION WHEN HIS INR WAS APPROPRIATE; HOWEVER, ON (B)(6) 2021 AROUND 22:24, A STAFF MEMBER WENT INTO THE PATIENTS ROOM FOR ROUTINE CARE AND FOUND HIM UNRESPONSIVE. A CODE BLUE WAS CALLED AND RESUSCITATIVE EFFORTS WERE INITIATED. EFFORTS CONTINUED UNTIL 22:48 WHEN EFFORTS WERE TERMINATED DUE TO NO RETURN OF SPONTANEOUS CIRCULATION. FOLLOWING THE CODE BLUE, THE PATIENTS MEDTRONIC HEARTWARE LVAD DEVICE WAS INTERROGATED AND INDICATED A LOSS OF POWER TO THE CONTROLLER. THE CONTROLLER POWER-UP EVENT WAS LOGGED AT THE TIME THE CODE BLUE WAS INITIATED AND IT APPEARS THAT THE CONTROLLER WAS OFF FOR APPROXIMATELY 12 MINUTES AND 18 SECONDS (PRIOR TO THE CODE BLUE). HOWEVER, IT WAS REPORTED THAT THERE WAS NO ALARM THAT WAS AUDIBLE TO THE NURSING STAFF WHEN THE DEVICE WAS NOTED TO HAVE LOST POWER, AS SHOULD HAVE BEEN THE CASE. FOLLOWING INTERVIEWS WITH NURSING STAFF, IT SEEMS THAT THE PATIENT MAY HAVE DISCONNECTED THE LVAD CONTROLLER FROM THE BATTERIES. A NURSE HAD BEEN PRESENT WITH THE PATIENT AND CHANGED THE BATTERIES LESS THAN TWO HOURS PRIOR TO THE EVENT. AT THAT TIME, THE BATTERIES WERE BOTH WORKING WELL BUT LATER IN THE EVENING THE BATTERIES WERE FOUND TO BE DISCONNECTED WHEN THE PATIENT CODED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1448900 MEDTRONIC HEARTWARE LVAD MEDTRONIC HEARTWARE LVAD DSQ MEDTRONIC 1103 17531288-1531

Patients

Seq Age Sex Outcome Treatment
1 77 YR Death