FDA Adverse Event Injury Summary report: N

ENDOTAK RELIANCE

MDR report key: 1853852 · Received October 5, 2010

Report

Report Number: 2124215-2010-15084
Event Type: Injury
Date Received: October 5, 2010
Date of Event: July 21, 2010
Report Date: July 21, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE AND LEAD SYSTEM REMAIN IN-SERVICE. THE EVENT WILL BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED AND/OR PRODUCTS ARE RETURNED FOR LABORATORY TESTING.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS EXHIBITING HIGH RV PACING IMPEDANCE MEASUREMENTS (1888 OHMS TO GREATER THAN 2000 OHMS). THE RV PACING IMPEDANCE MEASUREMENTS HAD BEEN IN THE 700 OHM RANGE. RV PACING THRESHOLDS AND SENSING HAVE BEEN NORMAL. TECHNICAL SERVICES SUGGESTED A CHEST XRAY AND FURTHER TROUBLESHOOTING. TECHNICAL SERVICES DISCUSS THE POSSIBILITY OF A LEAD DISLODGEMENT OR SET SCREW ISSUE. SUBSEQUENTLY, BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT A PERFORATION OF THE RV OCCURRED AND REQUIRED LEAD REPOSITIONING. AN ECHOCARDIOGRAM AND CHEST XRAY WERE PERFORMED. THERE WERE NO ADVERSE EVENTS FOLLOWING THE LEAD REPOSITIONING PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOTAK RELIANCE	IMPLANTABLE LEAD	NVY	CPI - DEL CARIBE	0184

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening\| R