PROTECTA CRT-D

Report

Report Number: 3004209178-2012-12373
Event Type: Death
Date Received: December 29, 2012
Date of Event: November 30, 2012
Report Date: February 27, 2013
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: NIK
PMA / PMN Number: P010031
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

PRODUCT ID: 5076-52, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT ID: 419688, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT ID: 694758, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD EXPIRED AT HOME. THE FAMILY OF THE PATIENT IS QUESTIONING THE DEVICE PERFORMANCE. NO SPECIFIC COMPLAINT HAS BEEN MADE. NO COMPLAINTS OR ALLEGATIONS HAVE BEEN MADE BY A HEALTH PROFESSIONAL. THE CAUSE OF DEATH LISTED ON THE DEATH CERTIFICATE IS NATURAL CAUSES. THE PATIENT HAD A HISTORY OF CARDIOMYOPATHY AND CONGESTIVE HEART FAILURE. SPECIFIC INFORMATION ABOUT THE PATIENT'S DEATH HAVE BEEN REQUESTED AND NOT BEEN MADE AVAILABLE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD EXPIRED AT HOME. THE FAMILY OF THE PATIENT IS QUESTIONING THE DEVICE PERFORMANCE. NO SPECIFIC COMPLAINT HAS BEEN MADE. NO COMPLAINTS OR ALLEGATIONS HAVE BEEN MADE BY A HEALTH PROFESSIONAL. THE CAUSE OF DEATH LISTED ON THE DEATH CERTIFICATE IS NATURAL CAUSES. THE PATIENT HAD A HISTORY OF CARDIOMYOPATHY AND CONGESTIVE HEART FAILURE. SPECIFIC INFORMATION ABOUT THE PATIENT'S DEATH HAVE BEEN REQUESTED AND NOT BEEN MADE AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROTECTA CRT-D	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO	NIK	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	D334TRG

Patients

Seq	Age	Sex	Outcome	Treatment
1	00078 YR		Death