FDA Adverse Event Injury Summary report: N

ENDOTAK RELIANCE

MDR report key: 1951532 · Received January 6, 2011

Report

Report Number: 2124215-2010-23066
Event Type: Injury
Date Received: January 6, 2011
Date of Event: November 28, 2010
Report Date: November 28, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
PMA / PMN Number: P910073
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS NEWLY-IMPLANTED RIGHT VENTRICULAR (RV) LEAD AND DEVICE WERE ASSOCIATED WITH A HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT DURING THE NEXT-DAY DEVICE CHECK. POST-IMPLANT IMPEDANCE MEASUREMENTS WERE NORMAL, AND DEFIBRILLATION THRESHOLD TESTING (DFT) WAS SUCCESSFUL AND HAD PRODUCED A NORMAL SHOCK IMPEDANCE MEASUREMENT. VECTOR TESTING ISOLATED THE ISSUE TO THE LEAD'S DISTAL COIL. THE DEVICE POCKET WAS REOPENED, AND THE LEAD'S DISTAL PIN PULLED FREE WHEN TUGGED; VISUAL EXAMINATION CONFIRMED THE DEVICE SETSCREWS WERE EXTENDED. THE SETSCREWS WERE RETRACTED AND THE LEAD RE-INSERTED AND SUCCESSFULLY CONNECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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			Required Intervention	N119\| 4968\| 0158\| 4136