THINLINE II STEROX

MDR report key: 1951421 · Received January 6, 2011

Report

Report Number: 2124215-2010-23034
Event Type: Injury
Date Received: January 6, 2011
Date of Event: November 28, 2010
Report Date: November 28, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE ATRIAL LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT TWO DAYS POST IMPLANT, THIS ATRIAL LEAD BECAME DISLODGED. A REVISION PROCEDURE WAS PERFORMED; THE LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	THINLINE II STEROX	IMPLANTABLE LEAD	NVN	CPI - DEL CARIBE	4370

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention