FDA Adverse Event Injury Summary report: N

ENDOTAK RELIANCE

MDR report key: 2911551 · Received January 11, 2013

Report

Report Number: 2124215-2012-17380
Event Type: Injury
Date Received: January 11, 2013
Date of Event: November 29, 2012
Report Date: December 28, 2012
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
PMA / PMN Number: P910073
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE MEMORY DUMP FILE WAS RETURNED TO BOSTON SCIENTIFIC AND REVIEWED. IT WAS NOTED THAT ALL PACING IMPEDANCE MEASUREMENTS WERE SATURATED ABOVE 2000 OHMS. CURRENTLY, THE LEAD REMAINS IMPLANTED AND IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Additional Manufacturer Narrative · 1

THE LEAD COULD NOT BE RETRIEVED AFTER THE PROCEDURE AND THEREFORE WILL NOT BE RETURNED FOR ANALYSIS. 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 RIGHT VENTRICULAR LEAD DISPLAYED PACING IMPEDANCE LEVELS GREATER THAN 2000 OHMS, ALONG WITH SLIGHTLY INCREASED PACING THRESHOLDS. NO OTHER DIAGNOSTIC ISSUES, NOISE ON THE LEAD, OR IMPACT TO PACING WERE NOTED. A MEMORY DUMP WAS PERFORMED TO INVESTIGATE THE LEAD ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD WAS EXPLANTED AND REPLACED DUE TO THE IMPEDANCE ISSUE. NO ADVERSE PATIENT EFFECTS OTHER THAN THE ADDITIONAL PROCEDURE WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
17711	ENDOTAK RELIANCE	IMPLANTABLE LEAD	NVY	CPI - DEL CARIBE	0175

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| L