FDA Adverse Event Malfunction Summary report: N

INSIGNIA

MDR report key: 3041125 · Received April 8, 2013

Report

Report Number: 2124215-2013-00928
Event Type: Malfunction
Date Received: April 8, 2013
Date of Event: November 21, 2012
Report Date: January 14, 2013
Manufacturer: GUIDANT CLONMEL IRELAND
Product Code: NVZ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS UNABLE TO COMMUNICATE WITH A PROGRAMMER DUE TO THE DEVICE BEING PASSED ELECTIVE REPLACEMENT INDICATOR (ERI). THE BATTERY VOLTAGE WAS BELOW THE POWER SUPPLY REQUIREMENTS AND IT COULD NOT SUPPORT PACING AND TELEMETRY FUNCTIONS. THE DEVICE CASE WAS OPENED AND THE MIXED MODE INTEGRATED CIRCUIT (MMIC) WAS ISOLATED. HIGH POWERED VISUAL INSPECTION REVEALED DAMAGE TO THE SURFACE OF THE MMIC AND ELECTRICAL RUNS. THE LOCATION OF THE DAMAGE WAS IN A PORTION OF THE CIRCUITRY THAT CONTROLLED THE SENSING INPUT FOR THE DEVICE. THIS DAMAGE DID NOT AFFECT PACING. FINAL ANALYSIS CONCLUDED THIS DAMAGE OCCURRED DURING THE MANUFACTURING PROCESS.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS UNABLE TO BE INTERROGATED. IT WAS OBSERVED THAT THE DEVICE WAS PACING AT 50 PACED BEATS PER MINUTE AND THE PATIENT WAS IN AN ATRIAL TRACHYCARDIA. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THIS PRODUCT WAS EXPLANTED FOR NORMAL BATTERY DEPLETION (NBD). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
143311	INSIGNIA	IMPLANTABLE PULSE GENERATOR	NVZ	GUIDANT CLONMEL IRELAND	1297

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR			4459\| 4472\| 1297