FDA Adverse Event Malfunction Summary report: N

EASYTRAK 2

MDR report key: 1852628 · Received October 4, 2010

Report

Report Number: 2124215-2010-14255
Event Type: Malfunction
Date Received: October 4, 2010
Date of Event: July 14, 2010
Report Date: July 13, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: OJX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE WAS CAPPED/ABANDONED AND WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AND AN UPDATED REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A SYSTEM REVISION TO ASSESS THE LEFT VENTRICULAR (LV) LEAD DUE TO THE PATIENT'S WORSENING HEART FAILURE, THE EFFICACY OF THE LV LEAD CAME INTO QUESTION AND A CONDUCTOR FRACTURE WAS SUSPECTED DUE TO AN INCREASING PACING THRESHOLD (10V) AND HIGH PACING IMPEDANCE. HISTORY: WHEN THE N107 DEVICE WAS IMPLANTED IN 2009, A COMPETITOR'S Y ADAPTOR WAS USED TO CONNECT THE RIGHT VENTRICULAR (RV) AND LV LEADS TO THE DEVICE. DURING THE MOST RECENT REVISION, THE PHYSICIAN SUSPECTED AN ISSUE WITH THE Y ADAPTOR OR LV LEAD SO THE Y ADAPTOR AND LV & RV LEADS WERE REMOVED AND TESTED. THE RV LEAD PARAMETERS WERE FOUND TO BE WITHIN NORMAL RANGES; HOWEVER, THE LV LEAD WAS FOUND TO BE NON-FUNCTIONING AND EXHIBITED A PACING THRESHOLD GREATER THAN 10V IN ADDITION TO OUT-OF-RANGE PACING IMPEDANCE. OUTCOME: THE PHYSICIAN ELECTED TO LEAVE THE Y ADAPTOR AND RV LEAD IMPLANTED, PLUG THE LV PORT, CAP THE CHRONIC LV LEAD AND REPLACE IT WITH ANOTHER (COMPETITOR) LV LEAD VIA A POSTERIOR LATERAL VEIN WHEREUPON LV PACING WAS RESTORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1				2872\| 0165\| 4087\| 4542\| 1871\| N107