FDA Adverse Event Injury Summary report: N

VIRTUOSO DR

MDR report key: 2952800 · Received February 9, 2013

Report

Report Number: 3004209178-2013-01799
Event Type: Injury
Date Received: February 9, 2013
Report Date: November 20, 2012
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: IN, US
Reporter Occupation: PHYSICIAN

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.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 6947 IMPLANTABLE TACHY LEAD, (B)(6) 2008. (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 BATTERY DID NOT LAST AS LONG AS EXPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEVICE BATTERY DID NOT LAST AS LONG AS EXPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICA TIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
57626	VIRTUOSO DR	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER	LWS	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	D154AWG

Patients

Seq	Age	Sex	Outcome	Treatment
1	00085 YR		Hospitalization\| R	5076 IMPLANTABLE PACING LEAD