FDA Adverse Event Injury Summary report: N

VIRTUOSO VR

MDR report key: 2811621 · Received October 31, 2012

Report

Report Number: 6000144-2012-06090
Event Type: Injury
Date Received: October 31, 2012
Manufacturer: MEDTRONIC MED REL, INC.
Product Code: LWS
PMA / PMN Number: P980016/S062
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC
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. EVALUATION SUMMARY (B)(4): THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. 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. EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED BATTERY DEPLETION WAS INDICATED (ERI) AND THE TIME OF RECOMMENDED REPLACEMENT TIME (RRT) IN THE SAVE TO DISK WAS ON (B)(6) 2012; THE DEVICE RRT WAS LESS THAN OR EQUAL TO 2.62 VOLTS. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS A MINIMUM BATTERY VOLTAGE EQUAL TO 2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2012 AND (B)(6) 2012. THERE WAS ONE PATIENT ALERT FOR LOW BATTERY VOLTAGE ON (B)(6) 2012.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEVICE DID NOT MEET LONGEVITY EXPECTATIONS AND TRIGGERED AN ALERT FOR RECOMMENDED REPLACEMENT TIME (RRT). THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. 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 VR	IMPLANTABLE PACEMAKER/CARDIO/DEFIB	LWS	MEDTRONIC MED REL, INC.	D154VWC

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Hospitalization\| R	6947 IMPLANTABLE TACHY LEAD