FDA Adverse Event Malfunction Summary report: N

INSIGNIA

MDR report key: 2040754 · Received April 6, 2011

Report

Report Number: 2124215-2011-00611
Event Type: Malfunction
Date Received: April 6, 2011
Date of Event: January 10, 2011
Report Date: January 11, 2011
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NVZ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, INITIAL TESTING REVEALED NORMAL INTERROGATION AND TELEMETRY OPERATIONS. THE DEVICE WAS SUBJECTED TO A LONGEVITY CALCULATION BASED ON SYSTEM GUIDE LABELING FOR THIS MODEL DEVICE AND WAS FOUND TO NOT MEET LONGEVITY. DESIGN ENGINEERS HAVE NOTED DEFICIENCIES IN THIS CALCULATION AND DETERMINED THAT IT DOES NOT ACCURATELY REPRESENT THE DEVICE'S BATTERY PERFORMANCE. AS A RESULT, THE DEVICE LONGEVITY WAS TESTED A SECOND TIME, USING A REVISED LONGEVITY CALCULATOR THAT HAS CORRECTED THE DEFICIENCIES OF THE ORIGINAL CALCULATOR. THIS DEVICE PASSED THE SECOND LONGEVITY CALCULATION.

Additional Manufacturer Narrative · 1

ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED FOR UNSPECIFIED REASONS. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION. THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

Description of Event or Problem · 1

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR			1298\| 1230\| 4269\| 4262