FDA Adverse Event Death Summary report: N

VICTORY XL SR

MDR report key: 2970459 · Received February 20, 2013

Report

Report Number
2017865-2013-01322
Event Type
Death
Date Received
February 20, 2013
Date of Event
January 15, 2012
Manufacturer
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
Product Code
LWP
PMA / PMN Number
P880086
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FL
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

NO MEDWATCH FORM WAS RECEIVED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
74711 VICTORY XL SR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5610 NA

Patients

Seq Age Sex Outcome Treatment
1 87 YR Death (B)(4)