FDA Adverse Event Injury Summary report: N

ALTRUA

MDR report key: 1863663 · Received October 11, 2010

Report

Report Number: 2124215-2010-15721
Event Type: Injury
Date Received: October 11, 2010
Date of Event: August 3, 2010
Report Date: August 3, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NVZ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

AS THE PRODUCT REMAINS IN SERVICE, IT WILL NOT BE RETURNED FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION RELATED TO THIS EVENT AVAILABLE TO THE COMPANY AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED SYNCOPE. IT WAS NOTED THAT A VENTRICULAR TACHYCARDIA (VT) EPISODE WAS RECORDED IN THE ARRHYTHMIA LOGBOOK WITH NO DURATION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED THE SALES REPRESENTATIVE (SR) THAT THIS TYPE OF AN EVENT DOES NOT HAVE EXIT CRITERIA AND THE MAXIMUM RATE WOULD BE 300 BPM. THE SR ALSO NOTED THAT THE VT RHYTHM DID NOT BREAK, TO WHICH TS EXPLAINED THAT AN ELECTROGRAM WILL BE STORED ONCE THE CORRECT CRITERIA IS MET TO STORE THIS TYPE OF EPISODE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ALTRUA	IMPLANTABLE PULSE GENERATOR	NVZ	GUIDANT CRM CLONMEL IRELAND	S603

Patients

Seq	Age	Sex	Outcome	Treatment
1	89 YR		Hospitalization\| L	4469\| 4457\| S603