FDA Adverse Event Malfunction Summary report: N

FINELINE II

MDR report key: 2780721 · Received October 10, 2012

Report

Report Number: 2124215-2012-13334
Event Type: Malfunction
Date Received: October 10, 2012
Date of Event: September 17, 2012
Report Date: September 17, 2012
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

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

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS RIGHT ATRIAL (RA) LEAD FELL DURING A SYNCOPAL EPISODE. AFTER THE FALL, LOW P WAVES, LOSS OF CAPTURE AND SENSING OF VENTRICULAR EVENTS ON THE ATRIAL CHANNEL WERE OBSERVED. IT WAS SUSPECTED THAT THE LEAD HAD DISLODGED. IT WAS NOTED THAT THE PATIENT WAS NOT PACEMAKER DEPENDANT AND THERE WERE NO ALLEGATIONS RELATED TO THE PATIENT SYNCOPE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE ELECTROGRAMS (EGMS) AND NOTED WHAT APPEARED TO BE A NORMAL VENTRICULAR TACHYCARDIA (VT) OR SUPRAVENTRICULAR TACHYCARDIA (SVT) EVENT ON THE DAY OF THE PATIENT FALL. ADDITIONAL INFORMATION WAS PROVIDED THAT A LEAD DISLODGEMENT WAS CONFIRMED AND THE DEVICE WAS PROGRAMMED TO VVI. THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FINELINE II	IMPLANTABLE LEAD	NVN	CPI - DEL CARIBE	4480

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR			K173\| 4457\| 4480