FDA Adverse Event Other Summary report: N

MEDTRONIC

MDR report key: 1294003 · Received January 22, 2009

Report

Report Number
MW5009708
Event Type
Other
Date Received
January 22, 2009
Product Code
LWS
Report Source
Voluntary report
Reporter Location
AZ, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

WELL, ONE DAY IN 2008, PT CAME DOWN WITH THE "WHAT WE THOUGHT WAS THE FLU-FEVER-ACHES- DID NOT FEEL GOOD AT ALL. THE FLU WAS GOING AROUND ALSO. SO, I TREATED IT LIKE THE FLU. ONE MORNING, HE STARTED YELLING AND MAKING NONSENSE. TRIED TO STAND UP BUT FELL. I CALLED 911. IN HOSP, THEY FOUND THE LEADS HAD ROTTED INSIDE OF HIM. WHEN THEY TOOK IT OUT, DR FOUND PUS COMING OUT OF THE LEADS - GOING RIGHT INTO HIS BLOODSTREAM. HIS BLOOD WAS INFECTED AND AS A RESULT, PT WENT INTO COMA. MRSA ALSO SET IN, KIDNEYS SHUT DOWN, HE BLOATED UP LIKE A BALLOON. I HAD NEVER SEEN MY HUSBAND SO SICK. BEFORE THIS, PT MOWED THE LAWN, DROVE HIS NEW TRUCK ALL OVER, WENT HUNTING WITH HIS FRIENDS, LAUGHED A LOT. IT TOOK PT 6 MONTHS TO DIE. HIS BODY DIED PIECE BY PIECE, DAY BY DAY. WHEN THE KIDNEYS WENT, THE MRSA WAS GONE. BUT, WHEN THE KIDNEYS WORKED AGAIN, MRSA CAME BACK. HE NEVER BOUNCED BACK. THEY WANTED TO PUT ANOTHER PACE MAKER IN, BUT HE WAS NEVER WELL ENOUGH. IT WAS ALWAYS ONE THING AFTER ANOTHER. HE LEFT BEHIND A DAUGHTER WORKS IN ANIMAL HEALTH AND RESCUE AND A SON, THE REVEREND AND ME. THE INSURANCE COMPANY IS FIGHTING ME ON THIS ALSO. THEY SAY IT WASN'T AN ACCIDENT, BUT IT WAS. I DON'T HAVE THE MONEY OR KNOWLEDGE TO FIGHT THEM, BUT I AM DOING MY BEST. MY COMPUTER IS NOT WORKING, SO I AM HAVING TO WRITE THIS BY HAND "SORRY". HERE ARE 2 PICTURES THE GOOD ONE WAS TAKEN ABOUT 9 MONTHS BEFORE HE GOT SICK. THERE IS A BIG DIFFERENCE ISN'T THERE? ANYWAY, THIS WAS OUR STORY. THEY NEED TO PAY FOR HIS DEATH. THESE LEADS KILLED HIM. I HAD FOUND OUT THAT PEOPLE HAD DIED AS A RESULT OF FAULTY LEADS BEFORE PT. THEY NEED TO PAY FOR THE LOSS OF LIFE. A DELIBERATE ACT OF PUTTING PATIENTS AT HIGH RISK. THANK YOU FOR YOUR TIME. VERY RESPECTFULLY SUBMITTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTRONIC DEFIBRILLATOR LWS 7278
2 MEDTRONIC LEADS LWS 6949581D
3 MEDTRONIC LEADS LWS 507652

Patients

Seq Age Sex Outcome Treatment
1 35 YR