FDA Adverse Event Injury Summary report: N

AV PLUS DX BIFURCATED BIPOLAR

MDR report key: 1010958 · Received March 10, 2008

Report

Report Number
2017865-2008-00849
Event Type
Injury
Date Received
March 10, 2008
Date of Event
January 16, 2008
Manufacturer
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
Product Code
DTB
Removal / Correction Number
NA
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
IT
Reporter Occupation
PHYSICIAN

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 AV PLUS DX BIFURCATED BIPOLAR PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1368/58 NA

Patients

Seq Age Sex Outcome Treatment
1 * Required Intervention