FDA Adverse Event Injury Summary report: N

TELIGEN

MDR report key: 1863603 · Received October 11, 2010

Report

Report Number: 2124215-2010-15394
Event Type: Injury
Date Received: October 11, 2010
Date of Event: July 27, 2010
Report Date: August 13, 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

ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED; A PROCEDURE WAS PERFORMED AS THE NON-INVASIVE ATTEMPTS TO ELIMINATE THE ISSUE WERE UNSUCCESSFUL. UPON EXPOSING THE DEVICE, THE DEFIBRILLATION PORTS WERE DISCONNECTED, WIPED CLEAN AND RECONNECTED PRIOR TO MOVING THE LEAD. INTERROGATION REVEALED NORMAL SHOCK IMPEDANCE MEASUREMENTS. THE ISSUE WAS RESOLVED. ALL OTHER MEASUREMENTS WERE ACCEPTABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE DISPLAYED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. AN X-RAY WAS PERFORMED; IT WAS THOUGHT THE ISSUE MAY BE DUE TO A RIGHT VENTRICULAR LEAD MICRODISLODGEMENT. HOWEVER, THERE WAS CONCERN THAT THE ISSUE MAY BE DUE TO A CONNECTION ISSUE. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND RECOMMENDED PERFORMING ISOMETRIC MANEUVERS TO FURTHER ASSESS LEAD INTEGRITY. A SAVE TO DISK WAS ALSO SUGGESTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TELIGEN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	F110

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention