FDA Adverse Event Death Summary report: N

JOHNSON & JOHNSON (CORDIS)

MDR report key: 1022242 · Received April 1, 2008

Report

Report Number
MW5006085
Event Type
Death
Date Received
April 1, 2008
Date of Event
October 12, 2007
Manufacturer
CORDIS
Product Code
NIQ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PT HAD BARE METAL STENTS AND DRUG ELUTING STENTS WITH HIS HEART. THE DES WAS PLACED IN HIS LAD IN APRIL 2003 AFTER BEING APPROVED BY THE FDA. PT SUFFERED A SUDDEN DEATH IN 2007.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 JOHNSON & JOHNSON (CORDIS) CYPHER STENT NIQ CORDIS * A1102356
2 JOHNSON & JOHNSON (CORDIS) CYPHER STENT NIQ CORDIS A0203782

Patients

Seq Age Sex Outcome Treatment
1 * Death