FDA Adverse Event Malfunction Summary report: N

INGENIO

MDR report key: 3760936 · Received April 21, 2014

Report

Report Number: 2124215-2014-08904
Event Type: Malfunction
Date Received: April 21, 2014
Date of Event: January 15, 2014
Report Date: March 6, 2014
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NE
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE PACING AND SENSING FUNCTIONS OF THE DEVICE WERE VERIFIED TO BE OPERATING NORMALLY. REVIEW OF EVIDENCE SUBMITTED BY THE FIELD INDICATED THAT THE NOISE ON THE VENTRICULAR CHANNEL WAS CONSISTENT WITH TEMPORARY BODY FLUID INFILTRATION THROUGH THE SEAL PLUG, COUPLED WITH AIR ESCAPING THE SEAL PLUG. SETSCREW SEAL PLUGS ARE DESIGNED TO PERMIT SETSCREW WRENCH INSERTION YET PREVENT BODY FLUIDS FROM ENTERING THE HEADER CAVITIES. IF AN ACCESSORY SENSING PATHWAY IS PRESENT DUE TO FLUID INTRUSION, THERE IS A POTENTIAL FOR OVERSENSING AND, THUS, INHIBITION OF PACING OR DELIVERY OF INAPPROPRIATE THERAPY.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS PACEMAKER, NOISE WAS NOTED ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE NOISE OCCURRED RANDOMLY AND COULD BE RECREATED WITH POCKET MANIPULATION. THE POCKET WAS REOPENED AND THE RV LEAD WAS DISCONNECTED AND REINSERTED INTO THE HEADER. NOISE WAS AGAIN OBSERVED AND WAS STILL ABLE TO BE RECREATED WITH POCKET MANIPULATION. THE DEVICE WAS NOT IMPLANTED AND WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
239222	INGENIO	IMPLANTABLE PULSE GENERATOR	LWS	GUIDANT CRM CLONMEL IRELAND	K274

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR			K274\| 4087\| 4469\| K174