FDA Adverse Event Malfunction Summary report: N

FLEXTEND

MDR report key: 2910030 · Received January 11, 2013

Report

Report Number: 2124215-2012-15498
Event Type: Malfunction
Date Received: January 11, 2013
Date of Event: November 6, 2012
Report Date: November 6, 2012
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
PMA / PMN Number: P960006
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

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 RIGHT ATRIAL (RA) LEAD PACING IMPEDANCE WAS OUT OF RANGE, WITH A WARNING MESSAGE DISPLAYED FOR THE RA LEAD UPON INTERROGATION. THE HISTORY OF THE RA LEAD PACING IMPEDANCE MEASUREMENTS FLUCTUATED FROM 140 OHMS TO 1,500 OHMS. AN RA DISLODGEMENT WAS SUSPECTED IN THIS NON-PACER DEPENDENT PATIENT. THE PATIENT WAS BROUGHT IN FOR FURTHER REVIEW AND DECREASED PWAVES WITH INCREASED THRESHOLD MEASUREMENTS WERE OBSERVED. THE OUTPUT WAS REPROGRAMMED TO MAXIMUM AND CAPTURE WAS OBSERVED. THE PHYSICIAN ELECTED TO CONTINUE TO MONITOR THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
18781	FLEXTEND	IMPLANTABLE LEAD	NVN	CPI - DEL CARIBE	4086

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR			4086\| 4087\| 1290