CONFIENT

MDR report key: 1953784 · Received January 10, 2011

Report

Report Number: 2124215-2011-00113
Event Type: Injury
Date Received: January 10, 2011
Date of Event: December 10, 2010
Report Date: December 10, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED DUE TO EROSION. THE PATIENT RECENTLY LOST A SIGNIFICANT AMOUNT OF WEIGHT WHICH CONTRIBUTED TO THE EROSION. NO ADVERSE PATIENT EFFECTS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CONFIENT	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	E030

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR		Life Threatening\| R	0157\| 4261\| 1230\| E030\| 4470\| 4271\| 1861\| E110