FDA Adverse Event Injury Summary report: N

ALTRUA

MDR report key: 2050273 · Received April 12, 2011

Report

Report Number: 2124215-2011-03840
Event Type: Injury
Date Received: April 12, 2011
Date of Event: February 18, 2011
Report Date: April 8, 2011
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NVZ
PMA / PMN Number: P970003
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

AS OF TODAY, THE EXPLANTED PACEMAKER HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE PRODUCT IS RETURNED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A COMPREHENSIVE SERIES OF DIAGNOSTIC AND ELECTRICAL TESTS WERE CONDUCTED, VERIFYING THE PERFORMANCE OF PACING, SENSING, AND MEMORY RECORDING FUNCTIONS. THE CLINICAL OBSERVATIONS WERE NOT CONFIRMED DURING ANALYSIS.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD AND PACEMAKER DISPLAYED NOISE WHICH RESULTED IN OVERSENSING AND THE STORAGE OF VENTRICULAR TACHYCARDIA EVENTS. THE NOISE COULD BE REPRODUCED WITH ARM MOVEMENTS. THE LEAD IMPEDANCE AND THRESHOLD MEASUREMENTS WERE STABLE. THE RIGHT ATRIAL LEAD DISPLAYED NOISE AS WELL. THIS NOISE WAS NOT REPRODUCIBLE. THE PATIENT WAS NOT SYMPTOMATIC HOWEVER HE WAS PACEMAKER DEPENDENT THEREFORE A LEAD REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS ABANDONED SURGICALLY AND THE PACEMAKER WAS REPLACED DURING THE PROCEDURE. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE REVISION PROCEDURE

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	87 YR		Hospitalization\| L\| R	S602\| 4469\| 1298\| 4087