FDA Adverse Event Injury Summary report: N

ELLIPSE VR

MDR report key: 3914578 · Received July 3, 2014

Report

Report Number: 2938836-2014-13159
Event Type: Injury
Date Received: July 3, 2014
Date of Event: May 9, 2014
Manufacturer: ST. JUDE MEDICAL, INC., CRMD
Product Code: LWS
PMA / PMN Number: P910023
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A POWER-ON RESET. REVIEW OF THE DEVICE IMAGE INDICATED THAT ALERTS FOR SHORTED OUTPUT STAGE DETECTION AND OVER CURRENT DETECTION WERE OBSERVED. BENCH TESTING IDENTIFIED THAT THE OUTPUT CIRCUITRY WAS DAMAGED. THE CAUSE OF THE DAMAGED OUTPUT CIRCUITRY COULD NOT BE DETERMINED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN THE OPERATING ROOM DURING DEVICE CHANGE OUT, AND DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. A DEVICE DOWNLOAD WAS PERFORMED SUCCESSFULLY. UPON FURTHER INVESTIGATION, IT WAS NOTED THAT TWO ABORTED CHARGES WERE DETECTED AFTER SHOCK THERAPY WAS DELIVERED AND DID NOT CONVERT THE PATIENT. EXTERNAL DEFIBRILLATION WAS DELIVERED AFTER THE FAILED SHOCK. AFTER RESTORING THE DEVICE, CAPACITOR MAINTENANCE WAS PERFORMED, AND AN ALERT FOR POSSIBLE HV CIRCUIT DAMAGE WAS NOTED. THE DEVICE WAS EXPLANTED, AND LEAD WAS CAPPED. THE PATIENT WAS FINE AFTER THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
389904	ELLIPSE VR	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	ST. JUDE MEDICAL, INC., CRMD	CD1311-36	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Required Intervention	1580/65, RE14139