FDA Adverse Event Malfunction Summary report: N

PULSAR MAX

MDR report key: 1864059 · Received October 11, 2010

Report

Report Number: 2124215-2010-15851
Event Type: Malfunction
Date Received: October 11, 2010
Date of Event: July 7, 2010
Report Date: August 5, 2010
Manufacturer: GUIDANT CLONMEL IRELAND
Product Code: NVZ
PMA / PMN Number: D970003
Removal / Correction Number: Z-875/897-03
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, INITIAL TESTING CONFIRMED THERE WERE NO HARDWARE RESETS AND DEVICE EXCEEDED NOMINAL PREDICTED LONGEVITY. PRE DECONTAMINATION INSPECTION CONFIRMED ALL SEAL PLUGS AND SETSCREWS WERE INTACT. THE DEVICE WAS RETURNED WITH THE HEADER OFF THE PACEMAKER CASING. VISUAL OBSERVATION OF THE DEVICE HEADER CONFIRMED NO ANOMALIES. THE DEVICE HEADER WAS THEN DISASSEMBLED AND BOTH THE INNER AND OUTER SEALING RINGS WERE INSPECTED. EVIDENCE OF SILICONE TO SILICONE BONDING WERE FOUND IN THE VENTRICULAR CHANNELS OF THE INNER SEALS. BODY FLUID CONTAMINATION WAS ALSO NOTED IN THE ATRIAL BARRELS ALL THE WAY TO THE TIP SET BLOCKS. NO FURTHER TESTING WAS PERFORMED DUE TO THE DEVICE BEING RETURNED WITH THE HEADER DETACHED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THIS PACEMAKER REPLACEMENT PROCEDURE, BOTH ATRIAL AND VENTRICULAR LEADS WERE STUCK IN THE HEADER. THE ATRIAL LEAD WAS ABLE TO BE REMOVED, HOWEVER THE VENTRICULAR LEAD COULD NOT BE REMOVED. THE PHYSICIAN USED A BONE CUTTER AND PUSHED THE VENTRICULAR LEAD OUT OF THE HEADER. THE PACEMAKER WAS RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PULSAR MAX	IMPLANTABLE PULSE GENERATOR	NVZ	GUIDANT CLONMEL IRELAND	1270

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR			4017\| S606\| 1270\| 4035