FDA Adverse Event Malfunction Summary report: N

FLEXTEND

MDR report key: 1945857 · Received January 4, 2011

Report

Report Number: 2124215-2010-23187
Event Type: Malfunction
Date Received: January 4, 2011
Date of Event: October 12, 2010
Report Date: October 12, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
PMA / PMN Number: P960006
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 A BRADYCARDIA RATE WAS NOTED ON THE HEART MONITOR WHEN THIS PACEMAKER DEPENDENT PATIENT WAS IN THE HOSPITAL FOR KIDNEY TROUBLE. LOSS OF CAPTURE WAS SUSPECTED DUE TO A CHANGE IN THE PATIENT'S HEART CONDITIONS AND AN INCREASE IN THE RIGHT VENTRICULAR (RV) THRESHOLD MEASUREMENTS. THE PHYSICIAN INCREASED THE RV OUTPUT TO 6.5 VOLTS AT 0.6 MS PRIOR TO THE BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) INTERROGATING THE DEVICE. UPON INTERROGATION THE SR NOTED THAT THE RV LEAD IMPEDANCE MEASUREMENTS WERE STABLE AND NOISE WAS NOT ABLE TO BE REPRODUCED. IT IS UNKNOWN IF ANY ASYSTOLE ACCOMPANIED THE LOSS OF VENTRICULAR CAPTURE. THE CAUSE OF THE LOSS OF CAPTURE AND HIGH THRESHOLD MEASUREMENTS IS UNKNOWN; HOWEVER THERE IS SPECULATION THAT THE PATIENT'S CONDITION HAS PLAYED A ROLE IN THIS ISSUE. THE LEAD WAS LEFT IMPLANTED IN THE PATIENT AND THE PACEMAKER WAS LEFT SET TO HIGH VENTRICULAR OUTPUTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FLEXTEND	IMPLANTABLE LEAD	NVN	CPI - DEL CARIBE	4087

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR			4087\| 4086\| 1291