FDA Adverse Event Injury Summary report: N

FINELINE II

MDR report key: 2913691 · Received January 14, 2013

Report

Report Number: 2124215-2013-00422
Event Type: Injury
Date Received: January 14, 2013
Date of Event: December 19, 2012
Report Date: December 19, 2012
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT
Reporter Occupation: PHYSICIAN

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 PRESENTED TO THE HOSPITAL WITH RATES IN THE 30 BPM RANGE WITH COMPLAINTS OF LOW ENERGY LEVEL AND SHORTNESS OF BREATH. AN INTERROGATION REVEALED LOSS OF RIGHT VENTRICULAR (RV) CAPTURE AND LEAD IMPEDANCE MEASUREMENTS OF GREATER THAN 2500 OHMS. IT WAS NOTED THAT THE PATIENT HAD AN UNDERLYING VENTRICULAR ESCAPE RHYTHM, THUS NO ASYSTOLE WAS OBSERVED. AN X-RAY WAS TAKEN AND REVEALED NO OBVIOUS FRACTURE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED. WHEN POCKET WAS OPENED THERE WAS VISIBLE BLOOD IN THE RV LEAD AND RV PORT OF THE DEVICE'S HEADER. THE PHYSICIAN WAS UNABLE TO FIND ANY OBVIOUS FRACTURE OR INSULATION BREAK ON THE VISIBLE PROXIMAL PORTION OF THE RV LEAD. SINCE THE PHYSICIAN WAS UNSURE IF THERE WAS A LEAD FRACTURE IN A DIFFERENT SECTION OF THE LEAD OR A DEVICE HEADER ISSUE, BOTH PRODUCTS WERE REPLACED. THE RV LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
20597	FINELINE II	IMPLANTABLE LEAD	NVN	CPI - DEL CARIBE	4471

Patients

Seq	Age	Sex	Outcome	Treatment
1	91 YR		Hospitalization\| L\| R	4471\| S606\| K173\| 4470