InjuryFIN
POSSIS SUTURELESS MYOCARDIAL LEAD
Received Jan 22, 1996 · Event occurred Jan 2, 1996
Report 2124215-1996-00014 · MDR key 30265
Device
Product problems
- Material Discolored
- Leak/Splash
Patient
*
- Surgical procedure
Narrative
Description of Event or Problem
DURING A ROUTINE REPLACEMENT PROCEDURE OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE PT'S TWO MYOCARDIAL RATE SENSING LEADS WERE CAPPED AND REMOVED FROM SERVICE BECAUSE THE LEADS WERE DISCOLORED AND BLOOD WAS OBSERVED INSIDE THE LEADS. IMPLANTED-6/12/92. REMOVED FROM SERVICE-1/2/96. IMPLANTED-42 MO.