FLEXTEND

Report

Report Number: 2124215-2010-17819
Event Type: Malfunction
Date Received: October 19, 2010
Date of Event: September 7, 2010
Report Date: September 24, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, BOTH THE MECHANICAL AND THE ELECTRICAL PERFORMANCE OF THE LEAD UNDER COMPLAINT WERE SCRUTINIZED. THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE ELECTRICAL SPECIFICATIONS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

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 DURING A RECENT DEVICE UPGRADE PROCEDURE, IT WAS NOTED THAT THIS ATRIAL LEAD WAS DISLODGED. ALL ELECTRICAL DATA SHOWED OTHERWISE, SO IT IS UNKNOWN HOW LONG THE LEAD HAD BEEN DISLODGED. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A RECENT DEVICE UPGRADE PROCEDURE, IT WAS NOTED THAT THIS ATRIAL LEAD WAS DISLODGED. ALL ELECTRICAL DATA SHOWED OTHERWISE, SO IT IS UNKNOWN HOW LONG THE LEAD HAD BEEN DISLODGED. THE LEAD 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	76 YR			1296\| 4087\| 4086