FDA Adverse Event Injury Summary report: N

VIRTUOSO DR

MDR report key: 2955395 · Received February 11, 2013

Report

Report Number: 9614453-2013-00301
Event Type: Injury
Date Received: February 11, 2013
Date of Event: December 14, 2012
Report Date: December 14, 2012
Manufacturer: IPG MFG SWITZERLAND
Product Code: NIK
PMA / PMN Number: P980016
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. <(><<)>END>.

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE U.S., HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. (B)(4).

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEVICE HAD UNEXPECTED LONGEVITY WITH FOUR YEARS OF SERVICE. PREMATURE BATTERY DEPLETION WAS SUSPECT. THE PHYSICIAN WAS VERY DISAPPOINTED AND SUSPECTED AN ISSUE WITH THIS FAMILY OF DEVICES. THE DEVICE WAS EXPLANTED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
58518	VIRTUOSO DR	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER	NIK	IPG MFG SWITZERLAND	D164AWG

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R