FDA Adverse Event Malfunction Summary report: N

ATLAS

MDR report key: 4199238 · Received October 20, 2014

Report

Report Number
MW5038778
Event Type
Malfunction
Date Received
October 20, 2014
Date of Event
October 14, 2014
Report Date
October 20, 2014
Manufacturer
ST. JUDE MEDICAL
Product Code
LWS
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

PT HAS AN IMPLANTED DEFIBRILLATOR THAT HAD AN EARLY BATTERY DECLINE WHICH PUT THE PATIENT WELL INTO THE RESIDUAL ELECTIVE REPLACEMENT TIME, NEAR TO END OF LIFE OF THE DEVICE. PT HERE FOR ROUTINE F/U AND EVALUATION OF HIS DUAL CHAMBER, IMPLANTED DEFIBRILLATOR WITH PACEMAKER. DEVICE IS ST. JUDE MEDICAL ATLAS + DR V-243 SN#(B)(4) IMPLANTED (B)(6) 2007. ATRIAL LEAD IS ST. JUDE MEDICAL TENDRIL SCX 1488T SN#(B)(4)M IMPLANTED (B)(6) 2007. VENTRICULAR LEAD IS ST JUDE MEDICAL RIATA ST 7011 SN#(B)(4), IMPLANTED (B)(6) 2007. DEVICE SITS VERY LOW LEFT SIDE OF CHEST, VERY MOBILE IN CHEST. PT REPORTS AT TIMES IT MOVE OVER TO THE LEFT UNDER HIS AXILLA. THE WIRES CAN BE VISUALIZED AND EASILY PALPATED, AT RISK FOR INJURY. PT KNOWS TO PROTECT SITE. PT DENIES ANY UNCOMFORTABLE SYMPTOMS. NO SOB, NO PALPS. PACING 85 PERCENT ATRIUM AND <1 PERCENT VENTRICLE. TWO BRIEF AMS EPISODES NOTED TESTING NOT DONE TODAY AS BATTERY HAD SUDDEN DECLINE FROM 2.55V IN MARCH TO 2.4OV TODAY WITH 14. 1 SECOND CHARGE TIME. PRIOR BATTERY VOLTAGES WERE AS FOLLOWS: (B)(6) 2014 2.55V. (B)(6) 2013 2.5V, (B)(6) 2013 2.58V, (B)(6) 2012 2.58V LEAD IMPEDANCES STABLE 365 ATRIAL AND 259 VENTRICULAR, NO CHANGE FROM PRIOR VISIT. SIGNAL AMPLITUDE: P WAVE NOT MEASURED TODAY, R WAVE 8.7MV, STABLE. TECH SERVICES WAS CONSULTED RE: THIS EARLY BATTERY DEPLETION AND THEY AGREE IT IS AN ISSUE. THEY RECOMMEND SENDING THE DEVICE BACK TO ST. JUDE FOR EVALUATION UPON EXPLANT. THIS DEVICE HAD NO ALERT FOR ERI. PT WAS UNABLE TO DO REMOTE MONITORING. HE WA AWARE BATTERY WAS DECLINING AND NEEDED TO BE SEEN Q3-4 MONTHS IN CLINIC. PROGRAM: DDR 50-BPM, MAX SENSOR RATE 115BPM, AV/PV 225/200MS WITH VIP INTRINSIC SEARCH +70MS, OUTPUT 2V AT 0.5MS BOTH CHAMBERS TACHY MODE: VT 176BPM GETS ATPX3 THEN 25J, THEN 34J X 3 IF NEEDED; VF 200BPM GETS 34J X 6 IF NEEDED. ICD AT ERI-HALFWAY THROUGH TO EOL (2.35V) RECOMMEND URGENT CHANGEOUT WITH DEVICE RETURNED TO ST. JUDE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
667945 ATLAS NONE LWS ST. JUDE MEDICAL ATLAS + DR V-243

Patients

Seq Age Sex Outcome Treatment
1 0 YR