FDA Adverse Event Malfunction Summary report: N

TENDRIL SDX

MDR report key: 1011032 · Received March 10, 2008

Report

Report Number
2017865-2008-00773
Event Type
Malfunction
Date Received
March 10, 2008
Date of Event
January 8, 2008
Manufacturer
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
Product Code
DTB
Removal / Correction Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
TN, US
Reporter Occupation
PHYSICIAN

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1488TC/58 NA

Patients

Seq Age Sex Outcome Treatment
1 *