FDA Adverse Event Injury Summary report: N

VIRTUOSO DR

MDR report key: 1791526 · Received August 10, 2010

Report

Report Number: 6000094-2010-01441
Event Type: Injury
Date Received: August 10, 2010
Date of Event: December 24, 2009
Manufacturer: MEDTRONIC S.A.
Product Code: LWS
PMA / PMN Number: ASKU
Removal / Correction Number: Z-0130-2010
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. THE EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

Description of Event or Problem · 1

IT WAS REPORTED THE DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VIRTUOSO DR	IMPLANTABLE PACEMAKER/CARDIO/DEFIB	LWS	MEDTRONIC S.A.	D164AWG	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention