FDA Adverse Event Injury Summary report: N

INSIGNIA

MDR report key: 1950311 · Received January 6, 2011

Report

Report Number: 2124215-2010-22517
Event Type: Injury
Date Received: January 6, 2011
Date of Event: November 16, 2010
Report Date: February 17, 2011
Manufacturer: GUIDANT CLONMEL IRELAND
Product Code: NVZ
PMA / PMN Number: D970003
Removal / Correction Number: Z-0187-06 THRU Z-0190-06
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, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS EXPOSED TO AUTOMATED DIAGNOSTIC TESTS THAT VERIFIED THE PERFORMANCE OF PACING, SENSING AND RECORDING FUNCTIONS OF THE DEVICE AND NO ANOMALIES WERE FOUND. THIS DEVICE PERFORMED NORMALLY THROUGHOUT ANALYSIS, OPERATING AS DESIGNED.

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE MEASUREMENT HAD BEEN INCREASING FOR SEVERAL MONTHS AND AT THE CURRENT DEVICE INTERROGATION IT MEASURED GREATER THAN 2500 OHMS. THE RV LEAD THRESHOLD MEASUREMENT HAD ALSO RISEN TO 4.5 VOLTS AT 0.5 MS. DURING THE REVISION PROCEDURE, THE RV LEAD WAS SURGICALLY ABANDONED AND THE PACEMAKER WAS ELECTIVELY EXPLANTED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THE INVESTIGATION IS COMPLETE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INSIGNIA	IMPLANTABLE PULSE GENERATOR	NVZ	GUIDANT CLONMEL IRELAND	1298

Patients

Seq	Age	Sex	Outcome	Treatment
1	92 YR		Hospitalization\| L\| R	4055\| 1298\| (B)(4)\| 4054