FDA Adverse Event Injury Summary report: N

VIRTUOSO

MDR report key: 3863045 · Received June 10, 2014

Report

Report Number: 3004209178-2014-10963
Event Type: Injury
Date Received: June 10, 2014
Report Date: February 20, 2014
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LWS
PMA / PMN Number: P980016
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(4) 2014. OF NOTE, THE SERIOUS INJURY OF INFECTION IS NORMALLY SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORT SUBMISSION THAT SHOULD HAVE BEEN SUBMITTED ON (B)(4) 2014. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(4) 2014 AND REVEALED AN OUT OF SPECIFICATION ANALYSIS FINDING. AS THERE IS NEW INFORMATION THAT INDICATES A PRODUCT PERFORMANCE ISSUE THIS EVENT NO LONGER QUALIFIES FOR SUMMARY REPORTING AND IS THEREFORE BEING SUBMITTED AS A (B)(4). PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE RETURNED DEVICE FOUND A HIGH CURRENT DRAIN CONDITION DUE TO CURRENT LEAKAGE IN A CERAMIC CAPACITOR. CONCOMITANT PRODUCT: 0181, LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION. THE DEVICE WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
337635	VIRTUOSO	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER	LWS	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	D154AWG

Patients

Seq	Age	Sex	Outcome	Treatment
1	00060 YR		Hospitalization\| R	5076-52 LEAD