FDA Adverse Event Malfunction Summary report: N

SPRINT FIDELIS

MDR report key: 2890554 · Received November 27, 2012

Report

Report Number
2890554
Event Type
Malfunction
Date Received
November 27, 2012
Date of Event
November 7, 2012
Report Date
November 27, 2012
Manufacturer
MEDTRONIC, INC.
Product Code
LWS
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

NOTES FROM THE CARDIAC CONSULTATION: THE PATIENT "HAD A HISTORY OF AN ISCHEMIC CARDIOMYOPATHY. HE HAS HAD AN INFERIOR WALL MYOCARDIAL INFARCTION AND BECAUSE OF VENTRICULAR TACHYCARDIA, HAD A DUAL-CHAMBER DEFIBRILLATOR PLACED 6 YEARS AGO (WHICH HAS REACHED ERI - ELECTIVE REPLACEMENT INDICATOR). THE PATIENT HAS DONE WELL UNTIL RECENTLY WHEN HE BEGAN TO HAVE PALPITATIONS. INDEED, THE PATIENT RECEIVED AT LEAST TWO EPISODES OF ICD DEFIBRILLATOR THERAPY RESULTING IN AT LEAST ON ONE OCCASION HIGH ENERGY SHOCK. INTERROGATION OF HIS DEVICE BY HIS CARDIOLOGIST CONFIRMED THAT THE PATIENT HAD BEEN RECEIVING ATP (ANTI-TACHYCARDIA PACING) THERAPY IN ADDITION TO SHOCKS ON MULTIPLE OCCASIONS AND BECAUSE OF ELECTRICAL PARAMETERS MEASURED IN THE LEAD, THERE WAS A FEELING THAT SOME OF THIS THERAPY WAS INAPPROPRIATE AND RELATED TO A FRACTURE IN THE LEAD", A SINGLE COIL MEDTRONIC FIDELIS ELECTRODE. NOTES FROM THE OP REPORT: A STYLET WAS PASSED DOWN THE SINGLE COIL HIGH ENERGY DEFIBRILLATOR ELECTRODE. THIS FIDELIS LEAD WAS ON RECALL, BUT IT HAD ALSO DEMONSTRATED DYSFUNCTION WITH THE PATIENT RECEIVING WHAT WAS THOUGHT TO BE INAPPROPRIATE THERAPY AND WITH RESISTANCE CHANGES SUGGESTING LEAD FRACTURE. AFTER WITHDRAWAL OF THE ACTIVE FIXATION DEVICE, GENTLE TRACTION WAS APPLIED TO THE LEAD AND WE WERE ABLE TO REMOVE IT UP INTO THE RIGHT ATRIUM AT THE ATRIO-CAVAL JUNCTION, SUPERIOR VENA CAVAL JUNCTION. I COULD NOT REMOVE IT FURTHER AND APPEARED TO BE INTIMATELY ASSOCIATED WITH THE INTACT RIGHT ATRIAL PACING ELECTRODE.. A 14-FRENCH EXCIMER LASER WAS MOBILIZED... WE WERE ABLE TO REMOVE THIS LEAD IN ITS ENTIRETY WITHOUT DISRUPTING POSITION OF THE RIGHT ATRIAL LEAD. EXAMINATION OF THE LEAD UPON ITS REMOVAL WAS INDETERMINATE BECAUSE OF TRAUMA OF THE EXTRACTION PROCESS....THE PATIENT TOLERATED THE PROCEDURE WELL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SPRINT FIDELIS LEAD, DEFIBRILLATION LWS MEDTRONIC, INC. 6931 *

Patients

Seq Age Sex Outcome Treatment
1 74 YR