FDA Adverse Event Malfunction Summary report: N

EASYTRAK 3

MDR report key: 2910902 · Received January 11, 2013

Report

Report Number: 2124215-2012-15724
Event Type: Malfunction
Date Received: January 11, 2013
Date of Event: November 13, 2012
Report Date: November 13, 2012
Manufacturer: CPI - DEL CARIBE
Product Code: OJX
PMA / PMN Number: P010012
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WILL BE FURTHER MONITORED. 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 DURING A FOLLOW UP VISIT, THIS LEFT VENTRICULAR LEAD DISPLAYED INCREASED IMPEDANCE MEASUREMENTS THAT HAD INCREASED GREATER THAN FIVE HUNDRED OHMS SINCE THE LAST MEASUREMENT. IN ADDITION, LOSS OF CAPTURE AND INCREASED THRESHOLDS WERE OBSERVED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED FOR THEIR RECOMMENDATIONS AND AFTER REVIEWING THE DATA RECOMMENDED PROVOCATIVE LEAD TESTING. THE PATIENT WAS HOSPITALIZED AFTER RECEIVING AN INAPPROPRIATE SHOCK AND A SIMILAR ISSUE WITH THE RIGHT VENTRICULAR LEAD. FURTHER REVIEW OF THE DATA REVEALED THE MEASUREMENTS HAD INCREASED AFTER THE PATIENT WITH THIS LEAD HAD EXPERIENCED A FALL. FLUOROSCOPY DID NOT REVEAL ANY LEAD OR CONNECTION ISSUES. DURING THE RETESTING, NORMAL MEASUREMENTS WERE OBTAINED. ALL MEASUREMENTS HAVE REMAINED NORMAL. A DECISION WAS MADE TO FURTHER MONITORING THIS LEAD AND NOT PERFORM INVASIVE TESTING. THE PATIENT WAS DISCHARGED HOME. UPON FURTHER TS ADVICE, THE DEVICE WAS REPROGRAMMED FROM EXTENDED BIPOLAR TO UNIPOLAR SETTINGS. THIS LEAD WILL BE FURTHER MONITORED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
18673	EASYTRAK 3	IMPLANTABLE LEAD	OJX	CPI - DEL CARIBE	4549

Patients

Seq	Age	Sex	Outcome	Treatment
1