FDA Adverse Event Malfunction Summary report: N

ENDOTAK RELIANCE

MDR report key: 2910043 · Received January 11, 2013

Report

Report Number: 2124215-2012-15271
Event Type: Malfunction
Date Received: January 11, 2013
Date of Event: November 5, 2012
Report Date: November 5, 2012
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Product Problem: Yes
Report Source: Manufacturer report
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 THIS DEVICE SYSTEM DETECTED AN INCREASED SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. THE PATIENT WAS BROUGHT INTO THE CLINIC FOR REVIEW AND THE DEVICE MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS. ONCE THE PATIENT RETURNED HOME, THE OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OCCURRED AGAIN. THE PATIENT WAS BROUGHT BACK TO THE CLINIC AND THE DEVICE WAS REPROGRAMMED TO A DISTAL COIL TO CAN CONFIGURATION. THE PHYSICIAN WAS TO CONTINUE MONITORING THE DEVICE SYSTEM. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
16978	ENDOTAK RELIANCE	IMPLANTABLE LEAD	NVY	CPI - DEL CARIBE	0185

Patients

Seq	Age	Sex	Outcome	Treatment
1	83 YR			E143\| T165\| 0185\| 4087