FDA Adverse Event Malfunction Summary report: N

INCEPTA

MDR report key: 3761242 · Received April 21, 2014

Report

Report Number: 2124215-2014-08688
Event Type: Malfunction
Date Received: April 21, 2014
Date of Event: February 13, 2014
Report Date: March 20, 2014
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

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 FROM THE HEALTH CARE PROFESSIONAL (HCP) THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SHOWED DIFFERENT DATA THAN EXPECTED. THE LEFT VENTRICULAR PACE (LVP) PERCENTAGE HAS SKEWED AS SEEN ON REMOTE MONITORING SYSTEM HOWEVER THE PREVIOUS IN-OFFICE CHECKED WAS NORMAL. IT IS NOTED THE PATIENT EXPERIENCED CHRONIC ATRIAL FIBRILLATION (AF) AND ALL OTHER LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. A MEMORY DOWNLOAD WAS PERFORMED AND DETERMINED THAT THE DEVICE EXPERIENCED SINGLE EVENT UPSET (SEU) CAUSING THE LVP PERCENTAGE TO INCREASE DRAMATICALLY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE CALCULATION DIFFERENCES AT IN-OFFICE AND REMOTE MONITORING SYSTEM. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
240627	INCEPTA	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	N161

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR			H210\| N161\| 4543\| 4136\| 6949