FDA Adverse Event Injury Summary report: N

SPRINT QUATTRO

MDR report key: 2964460 · Received February 15, 2013

Report

Report Number: 2649622-2013-01879
Event Type: Injury
Date Received: February 15, 2013
Report Date: December 11, 2012
Manufacturer: MPRI
Product Code: LWS
PMA / PMN Number: P920015
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED TWO LEAD INTEGRITY ALERTS WERE TRIGGERED ON (B)(6) 2012. THERE WERE 167 VENTRICULAR SHORT INTERVAL COUNTS IN THE 1.92 DAYS BETWEEN (B)(6) 2012. THERE WERE 15 VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES LESS THAN OR EQUAL TO 213 MILLISECONDS (MS) ON (B)(6) 2012, 5 LEAD FAILURE PREDICTOR HIGH RATE NON-SUSTAINED EPISODES LESS THAN OR EQUAL TO 215 MS AVERAGE VENTRICULAR CYCLE LENGTH ON (B)(6) 2012, AND THERE WAS 1 VENTRICULAR FIBRILLATION EPISODE EQUAL TO 210 MS AVERAGE VENTRICULAR CYCLE LENGTH ON (B)(6) 2012.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS POSSIBLY FRACTURED AND NOISE WAS SEEN ON NON-SUSTAINED TACHYCARDIA EPISODES. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED AND THE HIGH VOLTAGE PORTION REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
67780	SPRINT QUATTRO	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER	LWS	MPRI	694465

Patients

Seq	Age	Sex	Outcome	Treatment
1	00058 YR		Hospitalization\| R	(B)(4) IMPLANTABLE DEFIBRILLATOR