FDA Adverse Event Injury Summary report: N

COGNIS

MDR report key: 2042390 · Received April 6, 2011

Report

Report Number: 2124215-2011-04585
Event Type: Injury
Date Received: April 6, 2011
Date of Event: January 17, 2011
Report Date: January 17, 2011
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NIK
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE WITHOUT ADDITIONAL COMPLICATION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD EXPERIENCED A SYNCOPAL EPISODE AND WAS FOUND UNCONSCIOUS. REVIEW OF DEVICE MEMORY REVEALED THE PATIENT HAD BEEN IN VENTRICULAR TACHYCARDIA (VT) WHICH ACCELERATED TO VENTRICULAR FIBRILLATION (VF). ANTITACHYCARDIA PACING (ATP) HAD BEEN DELIVERED, HOWEVER THE PATIENT DID NOT RECEIVE ANY SHOCKS. REVIEWED OF EPISODES REVEALED THE PATIENT HAD MULTIPLE EPISODES OF VT WITH ATP DELIVERED. THE RHYTHM WOULD GET ONE BEAT AWAY FROM THERAPY IN THE VF ZONE, THEN DROP BACK INTO THE VT ZONE FOR MORE ATP. TECHNICAL SERVICES DISCUSSED POSSIBLE AGONAL RHYTHM OR FUNCTIONAL UNDERSENSING. ATP WAS PROGRAMMED OFF AND SHOCKS ONLY WERE PROGRAMMED ON. ADDITIONAL REPROGRAMMING OPTIONS WERE BEING CONSIDERED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COGNIS	IMPLANTABLE CHF PULSE GENERATOR	NIK	GUIDANT CRM CLONMEL IRELAND	N119

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Life Threatening	5076\| N119\| (B)(4)\| 4194\| 6947