FDA Adverse Event Injury Summary report: N

VITALITY

MDR report key: 1852623 · Received October 4, 2010

Report

Report Number: 2124215-2010-14119
Event Type: Injury
Date Received: October 4, 2010
Date of Event: April 9, 2010
Report Date: July 13, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

UPON FURTHER INVESTIGATION, THE LOCAL REPRESENTATIVE REPORTED THAT THIS DEVICE WAS EXPLANTED IN (B)(6) 2010 TO A COMPETITOR DEVICE DUE TO POCKET EROSION. THE LOCAL BOSTON SCIENTIFIC REPRESENTATIVE WAS NOT PRESENT AT THE TIME OF THE REPLACEMENT PROCEDURE. THERE WERE NO ALLEGATIONS OR COMPLAINTS AGAINST THE DEVICE'S OPERATION OR FUNCTIONALITY. THE PHYSICIAN ELECTED TO REPLACE THE DEVICE DUE TO POSSIBLE CONTAMINATION (ERODED THROUGH THE SKIN) AND THE LEAD'S POSITION AND ORIENTATION WERE REVISED INSIDE THE POCKET. THE CHRONIC LEAD SYSTEM REMAINS IN-SERVICE AND THERE WAS NO REPORT THAT THE LEADS WERE EXPOSED. TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION IN JULY 2010 THAT THIS PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER). NO DEVCE TELEMETRY COULD BE ESTABLISHED AND NO BEEPING TONES WERE GENERATED WITH MAGNET APPLICATION. IT WAS SUSPECTED BASED ON INSPECTION OF THE POCKET SITE (NEW INCISION) THAT THE BOSTON SCIENTIFIC DEVICE MAY HAVE BEEN REPLACED. TECHNICAL SERVICES RECOMMENDED A CHEST XRAY TO VIEW THE DEVICE'S XRAY IDENTIFICATION (ID). A NON-BOSTON SCIENTIFIC ID WAS IDENTIFIED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VITALITY	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	T125

Patients

Seq	Age	Sex	Outcome	Treatment
1	29 YR		Hospitalization\| R	4470\| T125\| 0138