FDA Adverse Event Malfunction Summary report: N

TELIGEN

MDR report key: 1890001 · Received November 3, 2010

Report

Report Number: 2124215-2010-21063
Event Type: Malfunction
Date Received: November 3, 2010
Date of Event: December 15, 2009
Report Date: September 27, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

AS OF TODAY, AVAILABLE INFORMATION INDICATES THAT THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A LOCAL FIELD REPRESENTATIVE (FR) THAT DURING A ROUTINE WOUND CHECK, FINE NOISE WAS NOTED ON THE RIGHT VENTRICULAR (RV) CHANNEL OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE NOISE WAS OCCURRING WHEN THE PATIENT INSPIRED. THE NOISE WAS NOT OVERSENSED. A RISE IN THRESHOLD AND PACE IMPEDANCE WAS NOTED AS WELL. THE PATIENT WAS SEEN IN THE LABORATORY FOR EVALUATION BY THE PHYSICIAN. AN X RAY WAS PERFORMED AND NO OBVIOUS MOVEMENT OF THE LEAD WAS SEEN. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED WHICH RESULTED IN GOOD NUMBERS. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. A FOLLOW UP WAS SCHEDULED FOR ONE MONTH OUT. 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	83 YR			4136\| 0175\| E110