FDA Adverse Event Injury Summary report: N

FINELINE II

MDR report key: 1862172 · Received October 8, 2010

Report

Report Number: 2124215-2010-16013
Event Type: Injury
Date Received: October 8, 2010
Date of Event: July 15, 2010
Report Date: July 27, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL INSPECTION NOTED THAT THE COMPLETE LEAD WAS RETURNED. THERE WERE SET SCREW MARKS NOTED ON TERMINAL PIN AND RING. THERE WAS A CUT NOTED IN THE INSULATION AT 24 CM FROM PIN WHICH IS CORRESPONDING TO CUT IN THE SUTURE SLEEVE. NO CONDUCTOR COILS WERE EXPOSED AT CUT LOCATION SINCE EACH OF THEIR INDIVIDUAL INSULATION IS INTACT. THERE WAS DRIED BLOOD NOTED IN LUMEN SPORADICALLY "LIKELY ENTERED THROUGH CUT. ANALYSIS REVEALED THE LEAD INSULATION WAS CUT (THROUGH) LIKELY ASSOCIATED WITH SOME TYPE OF SUTURE SLEEVE INTERACTION SINCE A CORRESPONDING CUT ALSO WAS OBSERVED ON THE SUTURE SLEEVE ITSELF. DC RESISTANCE TESTING SHOWED CONDUCTIVE PATHS OF RETURNED LEAD TO BE IN SPECIFICATION. THIS DAMAGE WAS DETERMINED TO BE PROCEDURALLY INDUCED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT ONE DAY POST IMPLANT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOW SENSING AND LOSS OF CAPTURE AT MAX OUTPUTS. A CHEST XRAY WAS TAKEN AND DID NOT SHOW AN OBVIOUS DISLODGEMENT. A LEAD REVISION WAS PERFORMED AT WHICH TIME IT WAS NOTED THAT THERE WAS SOME BLOOD PRESENT IN THE LEAD LUMEN. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH A NON BSC LEAD. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FINELINE II	IMPLANTABLE LEAD	NVN	CPI - DEL CARIBE	4473

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention