FDA Adverse Event Death Summary report: N

CONCERTO II CRT-D

MDR report key: 4113866 · Received September 24, 2014

Report

Report Number: 3004209178-2014-17620
Event Type: Death
Date Received: September 24, 2014
Date of Event: December 2, 2011
Report Date: October 8, 2014
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: NIK
PMA / PMN Number: P010031
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICES ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. (B)(4).

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS FURTHER NOTED THAT NO ISSUE WAS IDENTIFIED THAT REQUIRED FULL ANALYSIS.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY TWO MONTHS AFTER DEVICE WAS REPLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
593482	CONCERTO II CRT-D	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO	NIK	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	D274TRK

Patients

Seq	Age	Sex	Outcome	Treatment
1	00086 YR		Death	6949-65 LEAD, 5076-52 LEAD, 4194-88 LEAD