TELIGEN

MDR report key: 1946073 · Received January 4, 2011

Report

Report Number: 2124215-2010-20273
Event Type: Malfunction
Date Received: January 4, 2011
Date of Event: September 2, 2010
Report Date: October 15, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT THIS DEVICE DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPIES FOR A CONDUCTED ATRIAL FIBRILLATION. THE ATRIAL RATE WAS INITIALLY DETECTED IN THE DEVICE'S VENTRICULAR TACHYCARDIA 1 (VT1) ZONE, WHICH WAS PROGRAMMED MONITOR ONLY AND WITH DETECTION ENHANCEMENTS ENABLED. AFTER THE RATE ACCELERATED AND WAS DETECTED IN THE VT ZONE, THE THERAPIES WERE DELIVERED BECAUSE THE DETECTION ENHANCEMENTS HAD ISSUED AN INHIBIT THERAPY DECISION WITH THE INITIAL DETECTION IN THE LOWER VT1 ZONE. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) AND THE REPRESENTATIVE DISCUSSED REPROGRAMMING THE MONITOR ONLY ZONE TO PROVIDE ATP ONLY, WHICH WAS DONE. THERE WERE NO ADVERSE PATIENT EFFECTS, AND THE DEVICE REMAINS IN SERVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TELIGEN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	E102

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR			E102\| 0158