FDA Adverse Event Injury Summary report: N

ENDOTAK RELIANCE

MDR report key: 2780102 · Received October 10, 2012

Report

Report Number: 2124215-2012-12120
Event Type: Injury
Date Received: October 10, 2012
Date of Event: September 6, 2012
Report Date: September 10, 2012
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE; THEREFORE, THIS INVESTIGATION IS CLOSED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS NOT CAPTURING AND THRESHOLD MEASUREMENTS COULD NOT BE OBTAINED. A REVISION PROCEDURE WAS PERFORMED. UPON OPENING THE POCKET; IT WAS NOTED THAT THE HELIX OF THE LEAD HAD MOVED AND WAS 'CRUSHED' INTO THE HEART WALL. THE HELIX WAS GENTLY PULLED BACK AND THE LEAD WAS SUCCESSFULLY REPOSITIONED WITH NORMAL MEASUREMENTS. THE LEAD REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOTAK RELIANCE	IMPLANTABLE LEAD	NVY	CPI - DEL CARIBE	0185

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R