FDA Adverse Event Summary report: N

RIATA

MDR report key: 2505624 · Received March 22, 2012

Report

Report Number
2505624
Date Received
March 22, 2012
Date of Event
February 10, 2012
Report Date
March 21, 2012
Manufacturer
ST. JUDE MEDICAL
Product Code
LWS
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

THIS PATIENT HAD A DUAL-CHAMBER ICD IMPLANTED 6 YEARS AGO. THE DUAL COIL RIGHT VENTRICULAR (RV) ICD ELECTRODE HAS SINCE BEEN THE SUBJECT OF AN FDA ADVISORY. THE PATIENT HAD DEVELOPED CONGESTIVE HEART FAILURE AND AN ATTEMPT WAS MADE AT UPGRADING HER TO A BIVENTRICULAR ICD 2 YEARS AGO. WHILE AN ICD CRT (CARDIAC RESYCHRONIZATION THERAPY) DEVICE WAS INSTALLED, THE CARDIOLOGIST COULD NOT CANNULATE THE CORONARY SINUS TO IMPLANT A CORONARY SINUS ELECTRODE. THE PATIENT HAD BEEN TREATED MEDICALLY, BUT HAS HAD RECENTLY THREE HOSPITALIZATIONS FOR CONGESTIVE HEART FAILURE AND IS ADMITTED AT THIS TIME FOR LEFT VENTRICULAR (LV) EPICARDIAL LEAD PLACEMENT IF ONCE AGAIN WE FAIL AT CORONARY SINUS LV LEAD PLACEMENT. THE RECALLED LEAD WAS REMOVED USING EXCIMER LASER TECHNOLOGY. THE LEAD WAS EXAMINED UNDER FLUOROSCOPY AND APPEARED TO BE INTACT. A NEW RV DUAL COIL ELECTRODE WAS PLACED. AN ATTEMPT WAS MADE TO PASS A CORONARY SINUS ELECTRODE, BUT UNABLE TO CANNULATE THE CORONARY SINUS, DESPITE HAVING AN INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IN PLACE TO ASSIST WITH THE LEAD EXTRACTION PROCESS. ACCORDINGLY, LEFT ANTERIOR MINI THORACOTOMY WAS MADE AND THE LV EPICARDIAL LEAD PLACED. THIS LEAD HAD GOOD PACING THRESHOLDS AND THESE THRESHOLDS WERE MAINTAINED AS WERE THE NEW RV PACING THRESHOLDS. POST-OP THE PATIENT HAD A PROGRESSIVE INCREASE IN HER ACTIVITIES AND MANAGEMENT OF HER PAIN AND WAS DISCHARGED HOME SUFFICIENTLY STRONG TO MANAGE HER OWN AFFAIRS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 RIATA LEAD, DEFIBRILLATION LWS ST. JUDE MEDICAL 7000/60 *

Patients

Seq Age Sex Outcome Treatment
1 66 YR