ST JUDE MEDICAL

Report

Report Number: MW5017567
Event Type: Death
Date Received: September 24, 2010
Date of Event: July 16, 2010
Report Date: September 24, 2010
Manufacturer: ST. JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT
Product Code: LWS
Adverse Event: Yes
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Description of Event or Problem · 1

MY SON WAS DRIVING HIS CAR AND PASSED OUT. HE EXPIRED (B)(6)2010. DEFIBRILLATOR FAILED TO DELIVER SHOCK DUE TO BROKEN LEAD. IN 2004, THE LEADS BROKE AND WERE REPLACED. THIS IS THE SECOND TIME THE LEADS BROKE DUE TO CORROSION. THERE IS NO WARNING TO LET PT KNOW LEADS HAVE BROKEN. MFR IS NOT ACCEPTING RESPONSIBILITY FOR THEIR BROKEN EQUIPMENT. I HAVE NO RECOURSE. I DIDN'T EVEN KNOW THE OLD LEADS WERE LEFT INSIDE MY SON'S BODY. NO ONE WILL HELP ME AND NO ONE CARES TO TAKE MY CASE. IF MY SON WAS HUNG BY A TOY THERE WOULD BE RECOURSE. TOY MFRS ARE MORE LIABLE.

Description of Event or Problem · 1

MY SON DIED BECAUSE THE LEAD WIRE TO HIS ICD WAR BROKEN. THE REPORT FROM ST. JUDE MEDICAL STATES: "THE INDIVIDUAL ANALYSES OF THE SUBJECT DEVICE - V-168- AND LEADS -702/65- WERE REVIEWED. IT WAS REPORTED THAT THE PT EXPIRED AND REVIEW OF THE SESSION RECORD INDICATED THAT THE DEVICE ATTEMPTED HIGH VOLTAGE THERAPY DELIVERY DURING A VF EPISODE. THE THERAPY WAS TRUNCATED DUE TO OUT OF RANGE -HIGH, >200 OHM- HIGH VOLTAGE LEAD IMPEDANCE -HVLI-DETECTION. THE THERAPY TRUNCATION RESULTED IN A SUSTAINED VF EPISODE... ANALYSIS OF THE 7020/60 LEAD NOTED ABRASION AND FRACTURE TO THE RV CABLE CONDUCTOR PAIR NEAR THE RV SHOCK COIL, APPROX BETWEEN 52.2 CM TO 53.4 CM FROM THE CONNECTOR PIN." THE REPORT GOES ON TO DESCRIBE THE ABRASION AND TESTING AND GIVES PICTURES. AT THE END OF THE REPORT, I NOTICED THERE WAS NO MENTION OF SENDING A COPY TO FDA SO, I AM MAKING SURE THAT I REPORT THIS TO YOU. I BELIEVE THE PRODUCT IS FAULTY AND CAUSED MY SON'S DEATH. THE LEAD WIRE CORRODED ONCE AND WAS LEFT IN HIS BODY AND NEW WIRES WERE PUT IN. THE NEW WIRES WERE CORRODED IN THE SAME SPOT THAT THE OLD WIRES WERE. THIS IS THE PLACE THAT THEY BROKE FOR THE SECOND TIME. WHEN I CONTACTED ST JUDE MEDICAL TO HAVE THE DEVICE RETURNED TO ME, THEY WERE WILLING TO SEND ME THE BATTERY BUT NOT THE LEAD WIRES. I HAD TO HAVE A LAWYER GET INVOLVED BEFORE THEY WERE WILLING TO RETURN THE LEAD WIRES. THEY NEVER EVEN SAID THEY WERE SORRY ABOUT HIS DEATH. NO ONE CONTACTED ME TO ASK ANY QUESTIONS ABOUT HOW MY DAUGHTER'S HEALTH WAS; SHE LOST BOTH FATHER AND BROTHER. THE ICD HAS NO WAY OF DETECTING THE WIRES ARE BROKEN AND THEN SOUNDING AN ALARM SOMEPLACE. THERE SHOULD BE A WARNING DEVICE LIKE THERE IS ON (B)(6); IT CAN TELL A CUSTOMER THAT THEIR TIRE PRESSURE IS LOW FROM HUNDREDS OF MILES AWAY. I TRIED TO TELL THAT TO SOMEONE FROM ST. JUDE MEDICAL AND THEY DIDN'T WANT TO HEAR IT. SHE SAID, "WE'RE WORKING ON IT". THE TOY MFRS ACCEPT MORE LIABILITY TO CONSUMERS THAN MEDICAL DEVICE MFRS; THAT IS NOT RIGHT. I TRUSTED MY SON'S LIFE TO THIS DEVICE, IT WAS NOT A TOY. MY SON WAS ACTIVE AND IN GOOD PHYSICAL SHAPE. HIS DOCTOR TOLD HIM HE COULD NOT DO REPETITIVE EXERCISES LIKE ROWING SO, HE QUIT THE CREW TEAM. HE ALWAYS KEPT HIS DOCTORS' APPOINTMENTS AND TOOK GOOD CARE OF HIS HEALTH. HE WAS INTERESTED IN ENLISTING IN THE (B)(6) AND COMPLETED THE (B)(6) IN COLLEGE BUT WAS REJECTED BECAUSE OF THE ICD. HE WAS READY TO GRADUATE WITH A BACHELORS DEGREE IN ELECTRICAL ENGINEERING AND HE HAD (B)(6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model
1	ST JUDE MEDICAL	DEFIB/S/P	LWS	ST. JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT	1581-65
2	ST. JUE MEDICAL	ICD	LWS	ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT	V-168
3	ST. JUDE MEDICAL	RIATA LEADS, RV	LWS	ST. JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT	7020/60

Patients

Seq	Age	Sex	Outcome	Treatment
1	23 YR		Congenital Anomaly\| D