FINELINE II

Report

Report Number: 2124215-2012-12794
Event Type: Injury
Date Received: October 10, 2012
Date of Event: September 11, 2012
Report Date: September 20, 2012
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
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 REGARDING THE REVISION PROCEDURE NOTING THAT THE PHYSICIAN CUT THE LEAD DURING DISSECTION AND THE LEAD RETRACTED INTO THE POCKET AND HAS EXPOSED WIRE THAT COULD NOT BE REACHED. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE POSSIBLE ISSUES OF THE EXPOSED WIRE. THE LEAD WAS CAPPED AND ABANDONED WITHOUT FURTHER INCIDENT. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

Additional Manufacturer Narrative · 1

THE CALLER WILL DISCUSS THE CLINICAL OBSERVATIONS WITH THIS PATIENT'S PHYSICIAN. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THIS LEAD HAS SUSTAINED A FRACTURE AND WAS SUBSEQUENTLY REMOVED FROM SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING NO CAPTURE AND IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS IN BIPOLAR AND UNIPOLAR CONFIGURATIONS. A REVIEW OF THE DAILY MEASUREMENTS REVEALED AN INCREASE FROM 360 OHMS TO GREATER THAN 2500 OHMS OVER A THREE MONTH TIME PERIOD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FINELINE II	IMPLANTABLE LEAD	NVN	CPI - DEL CARIBE	4470

Patients

Seq	Age	Sex	Outcome	Treatment
1	82 YR		Hospitalization\| L\| R	4469\| S606\| 4470