EASYTRAK 2

Report

Report Number: 2124215-2014-14587
Event Type: Injury
Date Received: October 1, 2014
Date of Event: October 1, 2013
Report Date: September 4, 2014
Manufacturer: CPI - DEL CARIBE
Product Code: NIK
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE LEAD WAS SIGNIFICANTLY DAMAGED DURING THE EXPLANT PROCEDURE, BUT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

Additional Manufacturer Narrative · 1

(B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED THAT THE LEAD WAS RETURNED IN TWO SEGMENTS SEVERED 17.9 CM FROM THE TERMINAL PIN. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE OF THE RETURNED SEGMENTS. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF RETURNED SEGMENTS FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES; HOWEVER, THE COMPLETE LEAD WAS NOT ABLE TO BE RETURNED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCES WHICH WERE MEASURED THROUGH THE DEVICE AND PACING SYSTEM ANALYZER. A LEAD FRACTURE WAS SUSPECTED, BUT COULD NOT BE CONFIRMED VISUALLY. THE PROXIMAL END WAS CUT BY THE PHYSICIAN TO EXTRACT THE LEAD AND THE VERY DISTAL END (DISTAL ELECTRODE) BROKE DURING THE PROCEDURE AND IS STILL IN THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
612230	EASYTRAK 2	IMPLANTABLE LEAD	NIK	CPI - DEL CARIBE	4543

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| L\| R	H230\| 4543