FDA Adverse Event Malfunction Summary report: N

VITALITY

MDR report key: 1944614 · Received January 3, 2011

Report

Report Number: 2124215-2010-19903
Event Type: Malfunction
Date Received: January 3, 2011
Date of Event: October 7, 2010
Report Date: October 7, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Removal / Correction Number: Z-1047-2007 TO Z-1055-20
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

TECHNICAL SERVICES DISCUSSED THIS WAS APPROPRIATE DEVICE FUNCTION PER PROGRAMMING HOWEVER THERE WAS UNCERTAINTY AS TO WHY THE RHYTHM WAS NOT CONVERTED. THIS WAS TO BE FURTHER REVIEWED AND DISCUSSED WITH THE PHYSICIAN. INFORMATION SUGGEST THIS DEVICE REMAINS IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS BROUGHT TO THE EMERGENCY ROOM. THIS PATIENT WAS FOUND CONSCIOUS AND RESPONSIVE AFTER RECEIVING ANTI-TACHYCARDIA PACING AND FIVE SHOCKS. THE DEVICE HAD EXHAUSTED THERAPY. A FIELD REPRESENTATIVE REPORTED THAT THE PATIENT'S RHYTHM HAD APPEARED TO BE A 1:1 SINUS TACH. THE THERAPIES HAD NOT APPEARED TO FULLY CONVERT THE RHYTHM. THE THERAPIES MIGHT HAVE SLOWED OR CONVERTED THE RHYTHM BRIEFLY. THE DEVICE SHOCKS MIGHT HAVE ALSO INDUCED VENTRICULAR TACHYCARDIA AS THE RHYTHM APPEARS TO THEN BE 2:1. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VITALITY	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	T125

Patients

Seq	Age	Sex	Outcome	Treatment
1	95 YR			4469\| 1861\| 1270\| 4456\| 0154\| T125