FDA Adverse Event Malfunction Summary report: N

FLEXTEND

MDR report key: 1945567 · Received January 4, 2011

Report

Report Number: 2124215-2010-19956
Event Type: Malfunction
Date Received: January 4, 2011
Date of Event: October 11, 2010
Report Date: January 11, 2011
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OK
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 RETURNED, TOTAL LENGTH = APPROX. 455MM. THERE WERE SET SCREW MARKS NOTED ON THE TERMINALS, ONE ON EACH. THERE WERE DEFORMED CONDUCTOR COILS ALONG WITH PUNCTURE HOLES IN THE INSULATION NOTED 115MM FROM THE TERMINAL PIN-APPEARS TO HAVE BEEN GRABBED WITH SOME TYPE OF TOOL. THERE WAS DRIED BLOOD/BODY FLUID NOTED IN THE HELIX HOUSING AND IN THE WINDOW AND THE HELIX WAS EXTENDED. DISLODGEMENT COULD NOT BE CONFIRMED HOWEVER FRACTURE OF THE LEAD CATHODE CONDUCTOR COIL WAS CONFIRMED. DUE TO THE LOCATION AND TYPE OF DAMAGE, IT WAS MOST LIKELY CAUSED BY ENTRAPMENT IN THE CLAVICLE FIRST RIB REGION.

Additional Manufacturer Narrative · 1

AS OF THIS DATE, THE LEAD HAS NOT BEEN RETURNED. IF THIS LEAD SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS EVENT WILL BE REOPENED AND UPDATED AS NECESSARY.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD DISLODGED. DURING THE EXPLANT PROCEDURE, THE HELIX WAS UNABLE TO BE RETRACTED AND THE LEAD BECAME CAUGHT IN THE PATIENTS TISSUE. WITH A GENTLE TUG, THE LEAD CAME FREE AND IT WAS EXPLANTED AND SUCCESSFULLY REPLACED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FLEXTEND	IMPLANTABLE LEAD	NVN	CPI - DEL CARIBE	4086

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR			4086\| 4087\| 1290