FDA Adverse Event Death Summary report: N

CURRENT PLUS DR, DF-4 CONNECTOR

MDR report key: 2834598 · Received November 15, 2012

Report

Report Number
2017865-2012-10478
Event Type
Death
Date Received
November 15, 2012
Date of Event
January 28, 2012
Manufacturer
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
Product Code
LWS
PMA / PMN Number
P910023
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
IL
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CURRENT PLUS DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2211-36Q NA

Patients

Seq Age Sex Outcome Treatment
1 39 YR Death (B)(4)