FDA Adverse Event Malfunction Summary report: N

TELIGEN

MDR report key: 2780637 · Received October 10, 2012

Report

Report Number: 2124215-2012-12906
Event Type: Malfunction
Date Received: October 10, 2012
Date of Event: September 10, 2012
Report Date: September 27, 2012
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
PMA / PMN Number: P960040
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS SEEN FOR AN IN-CLINIC FOLLOW UP. NO ADDITIONAL OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED. FLUOROSCOPIC IMAGING OF THE LEAD WAS PLANNED FOR A DATE IN THE FUTURE. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

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.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SHOCK IMPEDANCE MEASUREMENTS FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ANOTHER MANUFACTURER'S IMPLANTABLE DEFIBRILLATION LEAD, HAD BEEN TRENDING DOWN FROM THE 40 OHM RANGE TO THE 30 OHM RANGE AND ARE NOW OUT OF RANGE AT LESS THAN 20 OHMS. THE LOCAL FIELD REPRESENTATIVE REPORTED THAT STORED ELECTROGRAMS (EGM) APPEARED APPROPRIATE WITH NO NOISE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED A POSSIBLE LEAD INSULATION ISSUE AND RECOMMENDED PERFORMING A CHEST X-RAY. 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	E110

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR			1888TC\| 7120\| E110