FDA Adverse Event Injury Summary report: N

CADENCE DEFIBRILLATION LEAD

MDR report key: 218073 · Received April 9, 1999

Report

Report Number
2938836-1999-00073
Event Type
Injury
Date Received
April 9, 1999
Date of Event
March 1, 1999
Report Date
March 1, 1999
Manufacturer
ST.JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIV.
Product Code
LWS
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THE LEAD WAS EXPLANTED DUE TO A FRACTURE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CADENCE DEFIBRILLATION LEAD Implant DEFIBRILLATION LEAD LWS ST.JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIV. DP-5038 NA

Patients

Seq Age Sex Outcome Treatment
1 65 YR Other DP-5038, ML-150, ML-150, V-145B, THERAPY DATE: NA.