FDA Adverse Event Death Summary report: N

SENTINEL

MDR report key: 383834 · Received March 15, 2002

Report

Report Number
2184056-2002-00008
Event Type
Death
Date Received
March 15, 2002
Date of Event
February 11, 2001
Report Date
March 15, 2002
Manufacturer
ANGEION CORP
Product Code
LWS
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FR
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE DEVICE WAS EXPLANTED AFTER PT'S DEATH. EYE WITNESSES REPORTEDLY SAW NO SIGN OF DEVICE INTERVENTION AS PT EXPIRED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ANGEION CORP 2010 9630301B

Patients

Seq Age Sex Outcome Treatment
1 * Death