ENDOTAK RELIANCE

MDR report key: 1951483 · Received January 6, 2011

Report

Report Number: 2124215-2010-23014
Event Type: Injury
Date Received: January 6, 2011
Date of Event: November 23, 2010
Report Date: November 23, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED SHOCK IMPEDANCE GREATER THAN 125 OHMS APPROXIMATELY TWO MONTHS AFTER THE IMPLANT PROCEDURE. THE POCKET WAS OPENED AND REVEALED A LOOSE DISTAL SETSCREW. THE SETSCREW WAS TIGHTENED AND A SECURE CONNECTION WAS CONFIRMED. ALL DIAGNOSTICS WERE WITHIN RANGE. DEFIBRILLATION THRESHOLD TESTING WAS SUCCESSFUL. THE PATIENT HAD NOT RECEIVED ANY INAPPROPRIATE THERAPY AS A RESULT OF THE LOOSE CONNECTION. THE REPRESENTATIVE WONDERED WHY THE OUT OF RANGE SHOCK IMPEDANCE DID NOT MANIFEST SOONER IF THERE WAS A LOOSE CONNECTION. TECHNICAL SERVICES DISCUSSED THAT THE DEFIBRILLATION NEGATIVE PIN WAS LIKELY PUSHED INTO THE HEADER AT IMPLANT AND GRADUALLY WORKED ITS WAY OUT OF THE HEADER AS THE PATIENT REGAINED THEIR RANGE OF MOTION AFTER THE IMPLANT PROCEDURE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE AND LEAD REMAIN IN SERVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOTAK RELIANCE	IMPLANTABLE LEAD	NVY	CPI - DEL CARIBE	0158

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR		Required Intervention	H227\| 5816\| 4555\| 4136\| 0158