ENDOTAK RELIANCE

Report

Report Number: 2124215-2013-04236
Event Type: Injury
Date Received: April 10, 2013
Date of Event: February 15, 2013
Report Date: February 19, 2013
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

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 SHOCK LEAD IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WERE > 200 OHMS SINCE THE PATIENT'S GENERATOR CHANGE FIVE DAYS EARLIER. THE SHOCK LEAD IMPEDANCE WAS PROGRAMMED IN THE TRIAD CONFIGURATION AND THERE WAS NO FLUCTUATION WITH POCKET MANIPULATION. IMPEDANCES WERE CHECKED IN THE OTHER AVAILABLE VECTORS AND THOSE YIELDED > 200 OHM IMPEDANCES AS WELL. IT WAS SUSPECTED THERE WAS A DISTAL COIL CONNECTION ISSUE AS THAT COIL WAS COMMON TO ALL VECTORS. ADDITIONALLY AT THIS APPOINTMENT, THE PATIENT'S PACING MODE WAS REPROGRAMMED FROM VVIR TO DDD AS THE PATIENT WAS IN SINUS RHYTHM AND WAS HAVING SYMPTOMS DUE TO THE SINGLE CHAMBER PACING. FURTHER INFORMATION WAS RECEIVED THAT SURGICAL INTERVENTION WAS PERFORMED AND THIS RV LEAD WAS CAPPED; IT WAS NOTED THERE WAS A CONDUCTOR FRACTURE WITH THIS LEAD. A NEW RV LEAD WAS IMPLANTED AND THE SAME GENERATOR REMAINS IN SERVICE. NO OTHER ISSUES HAVE BEEN REPORTED AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE NOTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
149584	ENDOTAK RELIANCE	IMPLANTABLE LEAD	NVY	CPI - DEL CARIBE	0186

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Hospitalization\| L\| R	4555\| MISMATCH\| 0186\| N141\| H217