EASYTRAK 3

Report

Report Number: 2124215-2010-23750
Event Type: Injury
Date Received: January 7, 2011
Date of Event: December 2, 2010
Report Date: January 5, 2011
Manufacturer: CPI - DEL CARIBE
Product Code: OJX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Additional Manufacturer Narrative · 1

THIS PRODUCT IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

Description of Event or Problem · 1

THE LEAD WAS LATER RETURNED FOR ANALYSIS.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE DISLODGED. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH THIS LEAD WAS EXPLANTED TO IMPLANT A NEW LEAD WITHOUT BLOOD IN THE LUMEN. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EASYTRAK 3	IMPLANTABLE LEAD	OJX	CPI - DEL CARIBE	4548

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Required Intervention	4136\| 4543\| 4137\| 4592\| 4548\| H120