FDA Adverse Event Malfunction Summary report: N

COGNIS

MDR report key: 3043256 · Received April 9, 2013

Report

Report Number: 2124215-2013-02878
Event Type: Malfunction
Date Received: April 9, 2013
Date of Event: January 17, 2013
Report Date: March 20, 2013
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NIK
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT TACHYCARDIA THERAPY WAS PROGRAMMED OFF IN THE DEVICE AS THE PATIENT'S CONDITION HAS BEEN DETERIORATING POST CABG PROCEDURE. 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 DURING A ROUTINE IN-CLINIC FOLLOW UP, FAULT CODES WERE OBSERVED AND THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS OBSERVED TO BE IN SAFETY MODE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE AND PLACEMENT OF A LEFT VENTRICULAR ASSIST DEVICE (LVAD) FIVE DAYS PRIOR AND THE DEVICE WAS NOT IN ELECTROCAUTERY MODE AS THE PATIENT HAD AN INTRINSIC RHYTHM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
147189	COGNIS	IMPLANTABLE CHF PULSE GENERATOR	NIK	GUIDANT CRM CLONMEL IRELAND	N119

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR			4543\| 5076\| N119\| H170\| 0185