FDA Adverse Event Malfunction Summary report: N

ENDOTAK RELIANCE

MDR report key: 1852207 · Received October 4, 2010

Report

Report Number: 2124215-2010-15241
Event Type: Malfunction
Date Received: October 4, 2010
Date of Event: July 12, 2010
Report Date: July 12, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH PACING IMPEDANCE MEASUREMENT. ALL OTHER LEAD MEASUREMENTS ARE IN THE 500 OHMS RANGE. TECHNICAL SERVICES (TS) RECOMMENDED BRINGING THE PATIENT IN AND TROUBLESHOOT WITH A PROGRAMMER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THERE WERE NO OUT OF RANGE MEASUREMENTS SEEN THROUGH THE DEVICE WHEN IT WAS CHECKED IN-CLINIC THE FOLLOWING DAY. THE LOCAL FIELD REPRESENTATIVE INDICATED THAT NO X-RAY WAS PERFORMED AND THERE WERE NO PERFORMANCE ALLEGATIONS REPORTED. THE PATIENT WILL RESUME NORMAL FOLLOW-UP VISIT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOTAK RELIANCE	IMPLANTABLE LEAD	NVY	CPI - DEL CARIBE	0157

Patients

Seq	Age	Sex	Outcome	Treatment
1	88 YR			0157\| 1861\| E110\| 5076