FDA Adverse Event Death Summary report: N

CRT-D

MDR report key: 3842860 · Received May 27, 2014

Report

Report Number
MW5036364
Event Type
Death
Date Received
May 27, 2014
Date of Event
September 10, 2012
Report Date
May 23, 2014
Manufacturer
MEDTRONIC
Product Code
NIK
Report Source
Voluntary report
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

ON SEPTEMBER 10, 2012 MY MOTHER WAS IN CARDIAC ARREST AND HER CRT-D HAD FAILED NEVER SENDING ANY SHOCKS. DUE TO THE DEVICE TECH TURNING OFF ONE OF MY MOM LEADS IN (B)(4) 2012 ONE MONTH AFTER HEART SURGERY ON (B)(6) 2012. ON (B)(7) 2012, MY MOTHER ENTERED THE HOSPITAL AT 10:15 AM AND WAS GIVEN ASPIRIN. DOCTOR DID NOT ANSWER PAGES AND NO ONE FROM MEDTRONIC TO CHECK THE DEVICE. NOT LONGER AFTER SHE WENT INTO CARDIAC ARREST. HER HEART WAS FAILING AND THE EMERGENCY ROOM DOCTOR GAVE CPR. CRT-D NEVER WORKED CAUSING DAMAGE TO MY MOM'S HEART, BRAIN AND KIDNEYS. DUE TO A DELAY IN EMERGENCY ROOM AND THE DOCTOR NOT RESPONDING UNTIL HOURS LATER, SHE WAS TAKEN TO SURGERY AND WAS STABLE AND THEN SOMETHING WENT WRONG AFTER SURGERY IN THE ICU. THE DOCTOR SAID HE HAD PLACED HEART PUMP TO HELP PUMP BLOOD TO HER HEART, BUT WAS NOT AWARE OR NOTIFIED BY ON CALL DOCTOR THAT HER PUMP HAD FAILED TO WORK. MY MOM SUFFERED THROUGH THE NIGHT; THE ON CALL HEART DOCTOR WAS PAGED BUT DID NOT FIX THE PUMP, MY MOM HAD TWO BLOCKAGE AND MORE BY MORNING SHE WAS DEAD AT 8:30 AM ON (B)(6) 2012. THIS COULD HAVE BEEN PREVENTED. DUE TO NEGLECT AND DELAY; MY MOM DID NOT HAVE TO DIE. THAT I FEEL BOTH DEVICES WERE DEFECTIVE AND SHOULD HAVE BEEN RECALLED CAUSING MY MOM'S DEATH. THE NEGLECT AND DELAY FROM STAFF CONTRIBUTED TO HER DEATH ALSO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
310474 CRT-D DEFIBRILLATOR NIK MEDTRONIC D224TRK

Patients

Seq Age Sex Outcome Treatment
1 70 YR Death