ACUITY

MDR report key: 1944640 · Received January 3, 2011

Report

Report Number: 2124215-2010-19898
Event Type: Injury
Date Received: January 3, 2011
Date of Event: October 7, 2010
Report Date: October 19, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: OJX
PMA / PMN Number: P010012
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

A RETURN REQUEST WAS MADE FOR THESE PRODUCTS. THE LEAD WAS RETURNED AND DETAILED ANALYSIS IS PENDING.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR (B)(4) LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE COMPLETE LEAD WAS RETURNED AND THE HELIX MECHANISM WAS IN VERY GOOD CONDITION WITH NO SIGNS OF DAMAGE OR DEFECT. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING COULD NOT VERIFY THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN UPGRADE PROCEDURE BOTH THE 4593 AND THE 4549 LEFT VENTRICULAR LEADS WERE ATTEMPTED IMPLANTS. IT WAS REPORTED THAT THE ATTEMPTS WERE RELATED TO USING TOO LARGE A VESSEL FOR THE LEAD AND THAT THE LEAD WOULD NOT STAY IN PLACE. IN ADDITION, TWO INSTANCES OF STAINING WERE NOTED AFTER USING THE INNER CATHETER. THE PATIENT HAD EXPERIENCE NO HEMODYNAMIC DIFFICULTIES. THE PHYSICIAN ELECTED TO STOP THE CASE DUE TO EXPOSED FLUOROSCOPY TIME.

Description of Event or Problem · 1

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACUITY	IMPLANTABLE HF LEADS	OJX	CPI - DEL CARIBE	4593

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR			0157\| T175\| 4593\| 4549\| 5076\| E110