FDA Adverse Event Malfunction Summary report: N

EASYTRAK 2

MDR report key: 3052513 · Received April 11, 2013

Report

Report Number: 2124215-2013-03811
Event Type: Malfunction
Date Received: April 11, 2013
Date of Event: February 26, 2013
Report Date: March 1, 2013
Manufacturer: CPI - DEL CARIBE
Product Code: OJX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AS OF THIS DATE, THIS LEAD REMAINS IMPLANTED AND NO REVISION IS INTENDED. 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

ACCORDING TO AVAILABLE INFORAMTION, THIS LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS OBTAINED: A LEAD FRACTURE IS SUSPECTED. AS THE EJECTION FRACTION HAS NOT BEEN IMPAIRED BY THE ABSENCE OF THIS LEFT VENTRICULAR LEAD STIMULATION; NO LEAD REVISION IS INTENDED AT THIS TIME.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS LEFT VENTRICULAR LEAD DISPLAYED NO CAPTURE IN ALL CONFIGURATIONS AT MAXIMUM OUTPUT SETTINGS. IN ADDITION, IMPEDANCE MEASUREMENTS WERE HIGH OUT OF RANGE. IMPEDANCE TRENDING REVEALED A SUDDEN IMPEDANCE MEASUREMENT INCREASE. THE PATIENT WITH THIS LEAD IS NOT PACEMAKER DEPENDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
154590	EASYTRAK 2	IMPLANTABLE LEAD	OJX	CPI - DEL CARIBE	4542

Patients

Seq	Age	Sex	Outcome	Treatment
1