FDA Adverse Event Malfunction Summary report: N

IDENTITY ADX DR

MDR report key: 1011018 · Received March 10, 2008

Report

Report Number
2017865-2008-00789
Event Type
Malfunction
Date Received
March 10, 2008
Date of Event
January 1, 2008
Manufacturer
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
Product Code
DXY
Removal / Correction Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MO, US
Reporter Occupation
PHYSICIAN

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 IDENTITY ADX DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5380 NA

Patients

Seq Age Sex Outcome Treatment
1 *