FDA Adverse Event Injury Summary report: N

ENDOTAK RELIANCE

MDR report key: 1953548 · Received January 10, 2011

Report

Report Number: 2124215-2010-23966
Event Type: Injury
Date Received: January 10, 2011
Date of Event: December 10, 2010
Report Date: January 26, 2011
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE ALSO EXHIBITED AN INCREASE IN PACING THRESHOLD MEASUREMENTS. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACE THIS LEAD. THE LEAD WAS CAPPED AND SURGICALLY ABANDONED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

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 IMPLANTABLE RIGHT VENTRICULAR (RV) LEAD HAS A PACING IMPEDANCE MEASUREMENT GREATER THAN 3000 OHMS. THE INCREASE IN PACING IMPEDANCE HAS BEEN A GRADUAL CHANGE. NO INTERVENTION IS SCHEDULED. CURRENTLY THIS LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

Description of Event or Problem · 1

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOTAK RELIANCE	IMPLANTABLE LEAD	NVY	CPI - DEL CARIBE	0148

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Required Intervention	T165\| 1860\| T135\| 0148