ENDOTAK C

Report

Report Number: 2124215-2012-17109
Event Type: Injury
Date Received: January 14, 2013
Date of Event: December 18, 2012
Report Date: February 22, 2013
Manufacturer: CPI PLANT - LEWICKI
Product Code: NVY
PMA / PMN Number: P910073
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. IN ADDITION, THE DEVICE WAS ALSO REPLACED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXPERIENCED VENTRICULAR TACHYCARDIA (VT) FOR WHICH A SUCCESSFUL SHOCK WAS DELIVERED. POST SHOCK DELIVERY, SHOCK IMPEDANCE MEASUREMENTS HAD DECREASED SINCE IMPLANT TO A LOW OUT OF RANGE MEASUREMENT. AN INTERNAL TECHNICAL SERVICE (TS) CONSULTANT WAS CONTACTED AND PROVIDED WITH A DATA DOWNLOAD TO DETERMINE THE ACTUAL SHOCK LEAD IMPEDANCE VALUE. TS RECOMMENDED MONITORING THIS SYSTEM AS A SHORT COULD OCCUR IF A SHOCK IS DELIVERED. ENGINEERING REVIEWED THE DATA AND PROVIDED THE ACTUAL SHOCK LEAD MEASUREMENT WAS LESS THAN 12.5 OHMS. TS CONCLUDED THERE MAY BE A SHOCK LEAD ISSUE AND RECOMMENDED FURTHER LEAD INTEGRITY TESTING BE PERFORMED. NO ADVERSE PATIENT SYMPTOMS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
20163	ENDOTAK C	IMPLANTABLE LEAD	NVY	CPI PLANT - LEWICKI	0070

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Hospitalization\| L\| R