FDA Adverse Event Injury Summary report: N

EASYTRAK 2

MDR report key: 1952794 · Received January 7, 2011

Report

Report Number: 2124215-2010-24464
Event Type: Injury
Date Received: January 7, 2011
Date of Event: January 26, 2010
Report Date: April 13, 2011
Manufacturer: CPI - DEL CARIBE
Product Code: OJX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE LEAD REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Additional Manufacturer Narrative · 1

THE ABANDONED LEAD HAS NOT BEEN RETURNED FOR ANALYSIS THEREFORE BOSTON SCIENTIFIC CANNOT CONFIRM THIS CLINICAL OBSERVATION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD AND DEVICE DISPLAYED NOISE, HIGH THRESHOLD MEASUREMENTS, HIGH IMPEDANCE MEASUREMENTS AND LOSS OF CAPTURE IN ALL CONFIGURATIONS. THE FIELD REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO ASK IF THIS WAS DUE TO A CONNECTION ISSUE. TECHNICAL SERVICES SUSPECTED A LEAD FRACTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

OUR COMPANY RECEIVED ADDITIONAL INFORMATION THAT DURING THE LEAD REVISION PROCEDURE, THE LEAD WAS FOUND TO HAVE BEEN DISLODGED. THE LEAD WAS ABANDONED SURGICALLY AND SUCCESSFULLY REPLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EASYTRAK 2	IMPLANTABLE LEAD	OJX	CPI - DEL CARIBE	4518

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR			H175\| 0185\| 4470\| 4518