VIRTUOSO VR

Report

Report Number: 9614453-2014-01519
Event Type: Death
Date Received: June 27, 2014
Date of Event: January 1, 2014
Report Date: May 1, 2014
Manufacturer: IPG MFG SWITZERLAND
Product Code: LWS
PMA / PMN Number: P980016
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE AND FOLLOW UP INFORMATION RECEIVED. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. SPECIFIC CAUSE OF DEATH HAS BEEN REQUESTED AND WAS NOT RECEIVED BY THE TIME OF THIS REPORT. REFERENCED ARTICLE: PULMONARY FLUID OVERLOAD MONITORING IN HEART FAILURE PATIENTS WITH SINGLE AND DUAL CHAMBER DEFIBRILLATORS. J. CARDIOVASC. MED. 2014;15(4):307-314. (B)(4).

Description of Event or Problem · 1

A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). FAILURE MODES IN THE ARTICLE WERE NOTED AS: ¿FALSE POSITIVE HEART FAILURE EPISODES,¿ URGENT HEART TRANSPLANTATION, AND DEATHS. IT WAS ALSO NOTED THAT THE ALERTS WERE TURNED OFF FOR SOME PATIENTS. SOME PATIENTS REACTED TO THE ALERTS BY ¿SELF-ADJUSTING¿ THEIR MEDICATIONS, AND SOME PATIENTS DID NOT HEAR THE ALERTS. ADDITIONAL INFORMATION OBTAINED THROUGH FOLLOW UP WITH THE AUTHOR INDICATED THAT THE PATIENT EXPIRED DUE TO CARDIAC DEATH-NOT CLASSIFIED. ADDITIONAL SPECIFICS REGARDING DEATH HAVE BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
377746	VIRTUOSO VR	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER	LWS	IPG MFG SWITZERLAND	D164VWC

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death