FDA Adverse Event Injury Summary report: N

TELIGEN

MDR report key: 1853210 · Received October 5, 2010

Report

Report Number: 2124215-2010-14769
Event Type: Injury
Date Received: October 5, 2010
Date of Event: July 18, 2010
Report Date: October 21, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE AVAILABLE INFORMATION FROM OUR MEDICAL RECORDS DATABASE INDICATE THAT THIS PATIENT'S DEVICE AND COMPETITOR LEAD SYSTEM REMAIN IN-SERVICE. DESPITE REQUESTS TO THE FIELD, NO FURTHER INFORMATION CONCERNING THIS REPORT WAS RECEIVED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Additional Manufacturer Narrative · 1

THE AVAILABLE INFORMATION SUGGESTS THAT THE DEVICE AND COMPETITOR RIGHT VENTRICULAR (RV) DEFIBRILLATION .

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS COMPETITOR LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS PATIENT SPONTANEOUSLY DEVELOPED VENTRICULAR FIBRILLATION (VF). DESPITE DELIVERY OF MULTIPLE SHOCK THERAPIES (MAXIMUM NUMBER OF SHOCKS/EPISODE DELIVERED), THE ARRHYTHMIA WAS NOT TERMINATED DUE TO HIGH DEFIBRILLATION THRESHOLDS (DFT). THE COMPETITOR LOCAL REPRESENTATIVE ASKED IF THE DEVICE COULD REDETECT AND DELIVER SHOCK THERAPY AGAIN. TECHNICAL SERVICES RECOMMENDED THAT THE DEVICE'S TACHYCARDIA MODE FEATURE BE PROGRAMMED OFF AND THEN BACK TO MONITOR + THERAPY MODE TO RESTART THE DETECTION PROCESS AGAIN. THERE WERE NO ALLEGATIONS OR COMPLAINTS AGAINST THE DEVICE'S OPERATION OR FUNCTIONALITY.

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	65 YR		Hospitalization\| L	E102\| 7030