FDA Adverse Event Summary report: N

SPRINT FIDELIS

MDR report key: 1981714 · Received January 20, 2011

Report

Report Number
1981714
Date Received
January 20, 2011
Date of Event
November 29, 2010
Report Date
January 19, 2011
Manufacturer
MEDTRONIC
Product Code
LWS
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

THE PATIENT HAD AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND PACEMAKER ORIGINALLY PLACED 4 YEARS AGO. WE DO NOT HAVE A RECORD OF THAT SURGERY. THE PHYSICIAN NOTE FROM OVER 2 WEEKS AGO READS: "I HAVE EVALUATED THE PATIENT'S DEFIBRILLATOR TODAY AND IT IS APPARENT THAT HE HAS HAD A SUDDEN AND DRAMATIC INCREASE IN HIS RIGHT VENTRICULAR (RV) LEAD IMPEDANCE, CONSISTENT WITH LEAD FRACTURE IN THIS RECALLED SPRINT FIDELIS LEAD. HE HAD A LOT OF NOISE AND WAS SUPPRESSING HIS VENTRICULAR PACING, BUT HE ALSO HAS PACING SPIKES, WHICH ARE NOT CAPTURED. THEREFORE, HE WILL REQUIRE REVISION OF THIS DEFIBRILLATOR SYSTEM." THE PHYSICIAN IMPRESSION READS THAT THERE IS AN ACUTE FRACTURE OF THE PACE-SENSED PORTION OF THIS PATIENT'S RECALLED SPRINT FIDELIS LEAD. THIS HAS RESULTED IN SUPPRESSION OF PACING AND VENTRICULAR NON-CAPTURE WITH RESULTANT SYNCOPAL SPELLS. THE PATIENT HAS SEVERE ISCHEMIC CARDIOMYOPATHY WITH CLASS I TO II CONGESTIVE HEART FAILURE. THE OLD RV LEAD WAS CAPPED BECAUSE IT WAS BOUND UP AND DIFFICULT TO REMOVE AND A NEW RV PACE-SENSE LEAD WAS IMPLANTED. THE PATIENT WAS ADMITTED ONE WEEK AGO DUE TO AN INFECTED ICD AND THE ATRIAL LEAD, NEW RV LEAD AND CAPPED SPRINT FIDELIS LEAD WERE ALL EXPLANTED. A TEMPORARY PACEMAKER WAS INSERTED INTO THE RIGHT COMMON FEMORAL VEIN. ACCORDING TO THE OPERATIVE NOTE THE EXAMINATION OF EACH LEAD SHOWED NO EVIDENCE OF VEGETATION. THERE WAS SOME FIBROUS TISSUE CONNECTED TO THE DISTAL COIL OF THE DEFIBRILLATOR. THIS WAS A RECALLED LEAD AND WAS SENT TO RISK MANAGEMENT. DAYS LATER THE PATIENT HAD A NEW ICD IMPLANTED AND THE TEMPORARY PACER WAS REMOVED. THE PATIENT WAS DISCHARGED HOME A FEW DAYS LATER WITH HOME HEALTH TO GIVE ANTIBIOTICS.

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 76 YR CARDIAC DRUGS