FDA Adverse Event Injury Summary report: N

MEDTRONIC

MDR report key: 713643 · Received May 2, 2006

Report

Report Number
713643
Event Type
Injury
Date Received
May 2, 2006
Date of Event
March 15, 2006
Report Date
May 2, 2006
Manufacturer
MEDTRONIC
Product Code
LWS
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AR, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

FRACTURE OF VENTRICULAR LEAD AND DEFIBRILLATOR UNDER RECALL. PT PRESENTS WITH A HISTORY OF CORONARY ARTERY DISEASE. HE HAS TOTALLY OCCLUDED RIGHT CORONARY ARTERY AND CIRCUMFLEX ARTERY. HE UNDERWENT CORONARY ARTERY BYPASS GRAFT IN 2003. HE HAD A VEIN GRAFT TO THE LEFT ANTERIOR DESCENDING ARTERY, OBTUSE MARGINAL I AND II AND THE FIRST DIAGONAL AND POSTERIOR DESCENDING ARTERY. SUBSEQUENT TO THE BYPASS SURGERY HE DEVELOPED ATRIAL FIBRILLATION AND NONSUSTAINED VENTRICULAR TACHYCARDIA. HE UNDERWENT A DIAGNOSTIC ELECTROPHYSIOLOGY STUDY, WHICH REVEALED NORMAL SA NODAL FUNCTION WITH NORMAL AV NODAL FUNCTION AND NO EVIDENCE OF DUAL AV NODAL PHYSIOLOGY. HE HAD NORMAL HIS-PURKINJE RESPONSES WITH NO EVIDENCE OF INFRA-HIS BLOCK. RETROGRADE CONCEALED CONDUCTION WAS NOTED. THERE WAS NO INDUCIBLE SUSTAINED SUPRAVENTRICULAR TACHYCARDIA. WHILE PACING THE RIGHT VENTRICULAR APEX AT 400 MSEC AN INTRODUCTION OF A TRIPLE VENTRICULAR EXTRASYSTOLE AT COUPLING INTERVALS OF 250/210 AND 210 MSEC RESULTED IN INDUCTION OF SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA. HE THEN UNDERWENT PLACEMENT OF A 4TH GENERATION NON-THORACOTOMY PACING CARDIOVERTER DEFIBRILLATOR SYSTEM. THE PULSE GENERATOR IS A MEDTRONIC MARQUIS DR MODEL 7274. THE IMPLANTED ATRIAL LEAD IS A MEDTRONIC 5076-52. THE IMPLANTED RIGHT VENTRICULAR TRIPOLAR DEFIBRILLATION LEAD IS A MEDTRONIC SPRINT QUATTRO 6944-65. HIS EJECTION FRACTION IS NOTED TO BE 25-30%. HE ALSO HAS A HISTORY OF HAVING MYOCARDIAL INFARCTION IN THE PAST. HIS LAST ECHOCARDIOGRAM WAS IN 2005, WHICH REVEALED MILD LEFT VENTRICULAR ENLARGEMENT WITH AKINETIC INFERIOR TO POSTERIOR SEGMENT WITH EJECTION FRACTION OF 35-40%. THE LEFT ATRIAL SIZE WAS UPPER LIMITS OF NORMAL WITH A MEASUREMENT OF 3.8. CALCIFIED AORTIC VALVE STENOSIS WAS NOTED WITH A VALVE AREA OF 0.95 CM2. TRACE MITRAL AND TRICUSPID REGURGITATION WERE NOTED. NO PA SYSTOLIC PRESSURE WAS NOTED. HE WAS EVALUATED IN THE CLINIC IN 2006 AND WAS FOUND TO HAVE AN ELEVATED VENTRICULAR LEAD IMPEDANCE OF GREATER THAN 3000. IN THE OFFICE IT WAS RECHECKED AND RETURNED 2720 OHMS. ATRIAL SENSING ELECTROGRAM MEASURED 7 MV. VENTRICULAR SENSING ELECTROGRAM MEASURED 16 MV. ATRIAL THRESHOLD OF 0.06 MSEC AT 2 VOLTS. VENTRICULAR THRESHOLD WAS 0.1 MSEC AT 3.5 VOLTS. HIS DEVICE IS CURRENTLY UNDER ALERT BY MEDTRONIC FOR POSSIBLE BATTERY DEPLETION WITHIN 24 HOURS. HE IS BEING ADMITTED TO UNDERGO ICD GENERATOR CHANGEOUT WITH LEAD EXTRACTION OF HIS VENTRICULAR LEAD WITH INSERTION OF A NEW VENTRICULAR LEAD UNDER GENERAL ANESTHETIC IN THE CVOR WITH DR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTRONIC VENTRICULAR LEAD LWS MEDTRONIC 6944-65 *

Patients

Seq Age Sex Outcome Treatment
1 77 YR Required Intervention