FDA Adverse Event Injury Summary report: N

FLEXTEND II

MDR report key: 1852661 · Received October 4, 2010

Report

Report Number: 2124215-2010-14360
Event Type: Injury
Date Received: October 4, 2010
Date of Event: May 7, 2009
Report Date: July 14, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE EXPLANTED PRODUCTS WILL NOT BE RETURNED TO BOSTON SCIENTIFIC. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT ONE DAY AFTER THE IMPLANTATION OF THIS IMPLANTABLE LEAD, THE PATIENT DEVELOPED A HEMATOMA. THE POCKET WAS TREATED AND THE PATIENT WAS DISCHARGED. SEVERAL DAYS LATER, THE PATIENT RETURNED TO THE HOSPITAL FOR ANOTHER POCKET HEMATOMA AND INFECTION. THE POCKET WAS REVISED AND ANTIBIOTICS WERE ADMINISTERED. HOWEVER, THE INFECTION PERSISTED AND THE SYSTEM WAS THEN COMPLETELY EXPLANTED AND REPLACED WITH COMPETITOR'S PRODUCTS ON THE OPPOSITE SIDE FROM THE INITIAL IMPLANT. NO OTHER ADVERSE PATIENT EFFECTS WERE 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			Hospitalization\| L\| R