FORTIFY VR, U1.6 SJ4 ID

MDR report key: 5125355 · Received October 2, 2015

Report

Report Number: 3010215456-2015-29298
Event Type: Death
Date Received: October 2, 2015
Date of Event: August 28, 2015
Report Date: September 7, 2015
Manufacturer: ST. JUDE MEDICAL, INC. (CRM-KISTA)
Product Code: LWS
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS MONITORED DUE TO A SERIOUS CONDITION OF CARDIAC FAILURE, EXCESS POST-EXERCISE OXYGEN CONSUMPTION (EPOC) AND HIGH RISK FOR CATASTROPHIC DETERIORATION. IT WAS LATER REPORTED THAT THE PATIENT EXPIRED. UPON INTERROGATION OF THE DEVICE IT WAS NOTED THAT MULTIPLE SHOCKS WERE DELIVERED. THE PHYSICIAN STATED THE THERE IS SOME EVENT THAT WAS NOT SENSED ALTHOUGH, THE DEATH WAS NOT DUE TO THE DEVICE. REVIEW OF THE EPISODE REVEALED THAT, THE DEVICE IS WORKING IN ACCORDANCE HOW IT HAS BEEN PROGRAMMED. AS THEY HAVE PROGRAMMED A VT MONITORING ZONE BELOW PROGRAMMED VF ZONE, THE VF COUNTER IS RESET AT EACH VT RE-DIAGNOSIS, CONSEQUENTLY ON A NUMBER OF OCCASIONS VF DIAGNOSIS IS NOT REACHED BEFORE THE BIN IS EMPTIED AND VF BINNING HAS TO START OVER. THIS IS NORMAL DEVICE FUNCTION ACCORDING TO PROGRAMMED SETTINGS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
655460	FORTIFY VR, U1.6 SJ4 ID	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	ST. JUDE MEDICAL, INC. (CRM-KISTA)	CD1233-40Q	3668051

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death