FDA Adverse Event Injury Summary report: N

TELIGEN

MDR report key: 3052751 · Received April 11, 2013

Report

Report Number: 2124215-2013-04950
Event Type: Injury
Date Received: April 11, 2013
Date of Event: July 28, 2012
Report Date: February 24, 2013
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED TO BOSTON SCIENTIFIC AFTER EXPLANT. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN ACADEMIC CONFERENCE ABSTRACT THAT THE PATIENT IMPLANTED WITH THIS BOSTON SCIENTIFIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND A COMPETITIVE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD PRESENTED TO THE HOSPITAL BECAUSE THE DEVICE WAS ERODING THROUGH THE PATIENT'S SKIN. THE PATIENT HAD ALSO BEEN DIAGNOSED WITH A STAPHYLOCOCCUS INFECTION SEVERAL WEEKS EARLIER AS A RESULT OF THE RV LEAD AND THE PATIENT'S LOWERED IMMUNE SYSTEM. IT WAS REPORTED THAT AN X-RAY OF THE COMPETITOR LEAD CONFIRMED EXPOSED CONDUCTOR COILS DUE TO AN INSULATION BREACH. THE DEVICE WAS EXPLANTED AND DEBRIDEMENT OF THE POCKET WAS PERFORMED. THE CHRONIC LEADS WERE SEVERED AND PARTIALLY REMOVED. ONE WEEK LATER, THE POCKET WAS OPENED AND THE ABANDONED LEAD SEGMENTS WERE FULLY REMOVED. THE FOLLOWING MONTH A NEW SYSTEM WAS IMPLANTED ON THE PATIENT'S RIGHT SIDE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RIGHT ATRIAL LEAD WAS ALSO A COMPETITOR PRODUCT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
156348	TELIGEN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	F110

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| L\| R