ENDOTAK RELIANCE

MDR report key: 2911873 · Received January 11, 2013

Report

Report Number: 2124215-2012-17224
Event Type: Malfunction
Date Received: January 11, 2013
Date of Event: November 30, 2012
Report Date: December 21, 2012
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE RECEIVED.

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 THROUGH A REMOTE MONITORING SYSTEM THAT DETECTED AN OUT OF RANGE HIGH AND LOW SHOCK IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR RIGHT (RV) LEAD. THE PATIENT WAS BROUGHT IN FOR EVALUATION. NO NOISE OR OVERSENSING WAS OBSERVED AND ALL MEASUREMENTS WERE STABLE. THE PATIENT WAS SENT HOME. A REQUEST FOR LEAD STATUS AND RESOLUTION HAS BEEN SENT TO THE LOCAL FIELD REPRESENTATIVE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS NOT BROUGHT BACK IN. THE PATIENT HAD RECEIVED SHOCKS PRIOR WITH NORMAL IMPEDANCE AND SUCCESS. THE LOW AND HIGH ONLY OCCURRED ON ISOLATED SELF CHECKS AND BEFORE AND AFTER HAD BEEN NORMAL. DURING THE INITIAL FOLLOW UP WE DID EVERYTHING POSSIBLE TO RECREATE ANY ISSUES UNSUCCESSFULLY. THE PATIENT IS FOLLOWED BY REMOTE MONITORING AND THE CLINIC IS CONTINUING TO WATCH THIS CLOSELY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
17990	ENDOTAK RELIANCE	IMPLANTABLE LEAD	NVY	CPI - DEL CARIBE	0158

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR			4076\| E110\| 0158