ALTRUA

Report

Report Number: 2124215-2010-15996
Event Type: Injury
Date Received: October 11, 2010
Date of Event: August 6, 2010
Report Date: October 11, 2010
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

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

Additional Manufacturer Narrative · 1

UPON RECEIPT AT BOSTON SCIENTIFIC CRM RELIABILITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. NORMAL INTERROGATION WAS OBSERVED ON THE ZOOM PROGRAMMER. THE DEVICE WAS THEN SUBJECTED TO A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFY THE PERFORMANCE OF THE PACING AND SENSING FUNCTIONS OF THE DEVICE. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS.

Description of Event or Problem · 1

THIS DEVICE WAS LATER EXPLANTED DUE TO AN UPGRADE TO A HEART FAILURE DEVICE.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED A SYNCOPAL EPISODE AND THE PATIENT'S DEVICE WAS INTERROGATED. UPON INTERROGATION, THE THRESHOLD MEASUREMENTS WERE 1.8 VOLTS AND THE DEVICE OUTPUTS WERE SET APPROPRIATELY AT 4.0 VOLTS. THERE WERE 35 EPISODES OF VENTRICULAR TACHYCARDIA (VT) STORED IN THE DEVICE MEMORY THAT THE FIELD REPRESENTATIVE SUSPECTED MAY HAVE BEEN LOSS OF CAPTURE. THE EPISODES CORRELATED WITH THE PATIENT'S SYMPTOMS. THE ISSUE WILL BE DISCUSSED WITH THE PHYSICIAN FOR A FINAL CARE PLAN. TO DATE, NO FURTHER 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	72 YR		Life Threatening	4470\| 4469\| S603