FDA Adverse Event Injury Summary report: N

ENDOTAK RELIANCE

MDR report key: 1870938 · Received October 15, 2010

Report

Report Number: 2124215-2010-16958
Event Type: Injury
Date Received: October 15, 2010
Date of Event: August 24, 2010
Report Date: September 29, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. AS NO RETURN OF PRODUCT IS INTENDED, BOSTON SCIENTIFIC CRM CANNOT CONFIRM NOR DENY THIS REPORTED CLINICAL ALLEGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

Additional Manufacturer Narrative · 1

ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. WHEN ADDITIONAL INFORMATION IS RECEIVED, THIS EVENT WILL BE UPDATED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. IN ADDITION, THE DEVICE WAS REMOVED, REPLACED AND DISCARDED BY THE HOSPITAL. ACCEPTABLE MEASUREMENTS WERE OBTAINED POST PROCEDURE. IT WAS THOUGHT THE ISSUE WAS RESOLVED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED NOISE CAUSING OVERSENSING AND PACING INHIBITION GREATER THAN TWO SECONDS ASYSTOLE. IT WAS THOUGHT THE NOISE WAS DUE TO MYOPOTENTIALS. THE PATIENT WITH THIS LEAD HAS AN INTRINSIC AV BLOCK WITH SLOW ESCAPE RHYTHM. NO INAPPROPRIATE THERAPY WAS REPORTED. A REVISION PROCEDURE WILL BE PERFORMED IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening