FDA Adverse Event Injury Summary report: N

FLEXTEND

MDR report key: 1951057 · Received January 6, 2011

Report

Report Number: 2124215-2010-24252
Event Type: Injury
Date Received: January 6, 2011
Date of Event: November 18, 2010
Report Date: November 21, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
PMA / PMN Number: P960006
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE AND OVERSENSING WITH FOUR TO FIVE SECONDS OF ASYSTOLE FOR THIS PACEMAKER DEPENDENT PATIENT. IT WAS NOTED THAT ALL LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS AND THE RV LEAD SAFETY SWITCH HAD NOT TRIPPED. THE PHYSICIAN STATED WHEN THE PATIENT WAS IN THE INTENSIVE CARE UNIT OF THE HOSPITAL, SHE EXPERIENCED SYNCOPE WITH PACING INHIBITION AND FOUR TO FIVE SECONDS OF ASYSTOLE. IT WAS NOTED THAT THERE WERE NO NOISY ELECTROGRAMS STORED IN THE PACEMAKER AND POCKET MANIPULATION AND ISOMETRICS DID NOT CREATE NOISE. SEVERAL TROUBLESHOOTING STEPS WERE SUGGESTED BY BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INCLUDING PROGRAMMING THE DEVICE TO VOOR OR VOO IN ORDER TO MITIGATE THE VENTRICULAR OVERSENSING. TS SUSPECTS AN INTERMITTENT LEAD ISSUE AND THE PHYSICIAN WILL PERFORM FURTHER TROUBLESHOOTING TO DETERMINE THE CAUSE OF THIS ISSUE. A BOSTON SCIENTIFIC SALES REPRESENTATIVE IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CAUSE AND RESOLUTION TO THIS ISSUE. THE CLINICIAN STATED THEY WERE UNABLE TO DETERMINE IF THE PATIENT WAS SYMPTOMATIC.

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	84 YR		Hospitalization\| L	1190\| 4087\| 5076