FDA Adverse Event Injury Summary report: N

FLEXTEND II

MDR report key: 1862223 · Received October 8, 2010

Report

Report Number: 2124215-2010-16749
Event Type: Injury
Date Received: October 8, 2010
Date of Event: July 19, 2010
Report Date: August 27, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

BOSTON SCIENTIFIC, CRM WILL ANALYZE THIS DEVICE UPON RECEIPT AND PROVIDE ADDITIONAL INFORMATION ONCE THE TESTING HAS BEEN COMPLETED AND AN UPDATED REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

ACCORDING TO LAB ANALYSIS, THE DISLODGED LEAD COULD NOT BE CONFIRMED BY ANALYSIS. HISTORICALLY, ANALYSIS PERFORMED ON DISLODGED LEADS HAS NOT IDENTIFIED ANY DEVICE DEFECT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL EVENT. EXPERIENCE HAS SHOWN THAT THIS ISSUE IS LIKELY RELATED TO THE PATIENT'S CONDITION OR THE IMPLANT TECHNIQUE. ALSO, DISLODGEMENT TYPICALLY OCCURS CLOSELY FOLLOWING IMPLANT -- AS WAS THE CASE WITH THIS LEAD WHICH WAS IMPLANTED LESS THAN TWO MONTHS EARLIER -- WHEN AN OPTIMAL TISSUE TO LEAD INTERFACE IS NOT ACHIEVED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA), PACE/SENSE LEAD EXHIBITED HIGH PACING THRESHOLDS. AN X-RAY CONFIRMED THE RA LEAD HAD BEEN DISLODGED SO THE LEAD WAS EXPLANTED AND REPLACED. (DURING EXPLANT, THE CHRONIC LEAD'S HELIX ALSO APPEARED TO BE STUCK.) NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THE LEAD WAS REPLACED SUCCESSFULLY.

Description of Event or Problem · 1

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