ENDOTAK RELIANCE

Report

Report Number: 2124215-2010-22989
Event Type: Death
Date Received: November 30, 2010
Date of Event: October 5, 2010
Report Date: November 8, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

IT WAS NOTED THE RV LEAD AND ASSOCIATED DEVICE WERE NOT EXPLANTED, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANLAYSIS. AT THIS TIME, THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD CAUSED A PERFORATION. DRAINAGE WAS PERFORMED TO TREAT THE PERFORATION. IT WAS THEN NOTED DAYS LATER THIS PATIENT PASSED AWAY. THIS PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA (VT) AFTER RECEIVING ADRENALIN PERFUSION. THE PHYSICIAN CONFIRMED THE DEVICE TREATED THE VT EPISODE APPROPRIATELY. THIS PATIENT EXHIBITED SYMPTOMS OF DIZZINESS, TIREDNESS AND SHORTNESS OF BREATH. ADDITIONAL INFORMATION WAS RECEIVED THAT IT IS UNKNOWN WHETHER THE IMPLANT PROCEDURE CONTRIBUTED TO THIS PATIENT'S DEATH. IT WAS SUSPECTED THE DEATH COULD BE RELATED TO A PULMONARY EMBOLISM, OR A STENT THROMBOSIS WHICH PROVOKED SYNCOPE AND ELECTROMECHANICAL DISSOCIATION. AN ECHOCARDIOGRAPHY WAS ALSO PERFORMED, AND DID NOT SHOW A PERICARDIAL EFFUSION. THE ASSOCIATED PG WAS INTERROGATED POST-MORTEM, AND NO ARRHYTHMIA WAS RECORDED DURING SYNCOPE. THE REPRESENTATIVE IS WAITING FOR PRINTOUTS, AND WILL UPDATE BOSTON SCIENTIFIC AS SOON AS THEY ARE AVAILABLE FOR REVIEW. THERE WERE 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	60 YR		Death	4542\| P107\| 5076\| 0185