FLEXTEND II

Report

Report Number: 2124215-2011-05063
Event Type: Injury
Date Received: April 13, 2011
Date of Event: February 28, 2011
Report Date: February 28, 2011
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD FOUND THAT THE HELIX MECHANISM WAS RETRACTED AND DRIED BLOOD WAS NOTED AROUND THE HELIX BASE, EXTENDING INTO THE HELIX HOUSING. A LABORATORY TECHNICIAN TESTED THE HELIX MECHANISM AND FOUND IT WAS NONFUNCTIONAL. NEXT, RESISTANCE AND PRESSURE TESTING WAS THEN PERFORMED TO ASSESS THE LEAD'S ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN THE NORMAL RANGE. PAST EXPERIENCE HAS SHOWN THAT BLOOD INFILTRATION INTO THE HELIX HOUSING CAN NEGATIVELY IMPACT THE FUNCTION OF THE HELIX MECHANISM. WHEN BLOOD ENTERS THE HELIX HOUSING IT CAN GET TRAPPED AND COAGULATE WITHIN THE HELIX MECHANISM. THIS CAN ADD SIGNIFICANT RESISTANCE TO EXTENDING OR RETRACTING THE HELIX. BASED UPON YOUR CLINICAL OBSERVATION AND THE LABORATORY FINDINGS, WE BELIEVE THAT BODY FLUID INSIDE THE HELIX HOUSING CAUSED THE IRREGULARITY IN HELIX FUNCTION, AS COAGULATED BODY FLUID/TISSUE CAN IMPACT INTO THE TIP OF THE HOUSING, PREVENTING APPROPRIATE TIP TO TISSUE CONTACT.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD HAD DISLODGED FOR THE SECOND TIME. AN ISSUE WITH THE HELIX MECHANISM WAS SUSPECTED. THE LEAD WAS REMOVED, REPLACED, AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FLEXTEND II	IMPLANTABLE LEAD	NVN	CPI - DEL CARIBE	4096

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	S602\| 4096\| 4097