FDA Adverse Event Injury Summary report: N

ALTRUA

MDR report key: 2911417 · Received January 11, 2013

Report

Report Number: 2124215-2012-15823
Event Type: Injury
Date Received: January 11, 2013
Date of Event: November 25, 2012
Report Date: November 25, 2012
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NVZ
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS REPROGRAMMED AND REMAINS IN SERVICE. 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 THAT THE PATIENT WITH THIS DEVICE EXPERIENCED A SYNCOPAL EPISODE AND WAS HOSPITALIZED. A REVIEW OF THE ELECTROGRAM REVEALED BROAD COMPLEX TACHYCARDIA WHICH MAY HAVE BEEN SLOW VENTRICULAR TACHYCARDIA OR A PACEMAKER RELATED ISSUE. A REVIEW OF THE DEVICE MEMORY REVEALED NO ARRHYTHMIA DETECTIONS. IN ADDITION, NO DEVICE ISSUES WERE REVEALED. A RETROGRADE CONDUCTION TEST WAS PERFORMED. PACEMAKER-MEDIATED TACHYCARDIA (PMT) WAS INITIATED. THE DEVICE SETTINGS WERE REPROGRAMMED TO PREVENT FURTHER PMT. IT WAS THOUGHT THE PMT MAY HAVE CONTRIBUTED TO THE SYNCOPE OR THE PATIENT'S BLOOD PRESSURE RELATED ISSUES. THIS DEVICE WAS REPROGRAMMED AND REMAINS IN SERVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
18621	ALTRUA		NVZ	GUIDANT CRM CLONMEL IRELAND	S606

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| L\| R