FDA Adverse Event Malfunction Summary report: N

ENERGEN

MDR report key: 4131789 · Received October 1, 2014

Report

Report Number: 2124215-2014-15256
Event Type: Malfunction
Date Received: October 1, 2014
Date of Event: July 9, 2014
Report Date: July 9, 2014
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWP
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SYSTEM REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SYSTEM WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS AND INCREASED THRESHOLDS ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE FOLLOWING DAY, IMPEDANCE WAS BACK TO 1290-1350 OHMS RANGE; HOWEVER, THRESHOLD MEASUREMENTS WERE WORSE. THE CALLER STATED THAT THE QRS LOOKED BETTER WITH LEFT VENTRICULAR (LV) PACING SO THE PHYSICIAN ELECTED TO PROGRAM THE RV OUTPUT TO SUB- THRESHOLD AT 0.5V @ 0.4MS AND PACE VIA LV. THE PATIENT DID EXPERIENCE SOME POST-OPERATIVE STIMULATION. THE PHYSICIAN QUESTIONED A POTENTIAL PERFORATION BUT DID NOT PERFORM AN ECHOCARDIOGRAM TO CONFIRM. THE PATIENT HAS GOOD R-WAVE MEASUREMENTS AND NO PAIN DURING PACING. THE CALLER PROGRAMMED THE TACHYCARDIA DURATIONS A BIT LONGER THAN NOMINAL AND PLANS TO ENROLL IN THE PATIENT IN THE REMOTE MONITORING SYSTEM AND FOLLOW UP WITH THE PATIENT IN ONE WEEK¿S TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
612712	ENERGEN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWP	GUIDANT CRM CLONMEL IRELAND	N140

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR			0292\| 4548\| 4469\| N140