FDA Adverse Event Injury Summary report: N

ALTRUA

MDR report key: 1872761 · Received October 18, 2010

Report

Report Number: 2124215-2010-17273
Event Type: Injury
Date Received: October 18, 2010
Date of Event: August 27, 2010
Report Date: October 12, 2012
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NVZ
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

RECORDS INDICATE THIS DEVICE 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.

Additional Manufacturer Narrative · 1

THIS DEVICE REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

INFORMATION WAS LATER RECEIVED THAT THIS PATIENT EXPERIENCED CARDIOGENCI SYNCOPE. THE LEAD SAFETY SWITCH WAS TRIPPED ON THE RIGHT VENTRICULAR LEAD DUE TO UNKNOWN IMPEDANCE MEASUREMENTS. AS A RESULT, THE DEVICE WAS PROGRAMMED TO AAIR.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE RIGHT VENTRICULAR (RV) LEAD IMPLANTED WITH THIS PACEMAKER WAS SURGICALLY ABANDONED. A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE HAD 615 EPISODES OF VENTRICULAR TACHYCARDIA. THE AVAILABLE ELECTROGRAMS APPEARED TO BE NOISE THAT WAS OVERSENSED. NO ADVERSE PATIENT EFFECTS WERE NOTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ALTRUA	IMPLANTABLE PULSE GENERATOR	NVZ	GUIDANT CRM CLONMEL IRELAND	S602

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR		Life Threatening	4087\| 4469\| S602\| 1298