FDA Adverse Event Malfunction Summary report: N

FINELINE II

MDR report key: 1954204 · Received January 10, 2011

Report

Report Number: 2124215-2010-24681
Event Type: Malfunction
Date Received: January 10, 2011
Date of Event: December 15, 2010
Report Date: December 15, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
PMA / PMN Number: P960004
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE FIELD REPRESENTATIVE CHECKED THIS PATIENT AND NOTED THAT BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD'S WERE PROGRAMMED TO UNIPOLAR PACING AND SENSING AND WERE PICKING UP NOISE, SEVERAL INAPPROPRIATE STORED EPISODES WERE RECORDED. THE FIELD REPRESENTATIVE LATER SPOKE WITH THE NURSE AND SHE NOTED THAT THE LEAD SAFETY SWITCH (LSS) HAD BEEN TRIGGERED ONE YEAR EARLIER ON BOTH LEADS. UPON FURTHER EVALUATION THE FIELD REPRESENTATIVE NOTED THAT NOISE WAS NOTED WITH POCKET MANIPULATION, HOWEVER DID NOT ANY EFFECT ON THERAPY. THE PATIENT IS NOT PACEMAKER DEPENDANT, AND BOTH LEADS REMAIN PROGRAMMED TO UNIPOLAR MODE. NO 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	4469

Patients

Seq	Age	Sex	Outcome	Treatment
1	43 YR			S603\| 4136\| 4469