FDA Adverse Event Injury Summary report: N

SPRINT QUATTRO SECURE S

MDR report key: 2791529 · Received October 15, 2012

Report

Report Number: 2649622-2012-14840
Event Type: Injury
Date Received: October 15, 2012
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: LWS
PMA / PMN Number: P920015/S039
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GB
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY : (B)(4) : THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED OVERSENSING. THERE WERE 4 LEAD FAILURE PREDICTOR (LFP) HIGH RATE-NON-SUSTAINED (NS) EPISODES LESS THAN OR EQUAL TO 215 MS AVERAGE V-CYCLE ON (B)(6) 2012 IN THE TIMEFRAME BETWEEN 06:51:27 AND 06:55:23. INTERFERENCE/NOISE WAS ALSO NOTED. THE VENTRICULAR SHORT INTERVAL COUNT (V-SIC) WAS EQUAL TO 27.9 COUNTS AVG/DAY, IN 1.18 DAYS, BETWEEN (B)(6) 2012 06:37:57 AND (B)(6) 2012 11:02:42. THE LEAD INTEGRITY ALERT WAS TRIGGERED FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012 07:46:23.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR INTERMITTENT T-WAVE OVERSENSING (TWOS). THE DEVICE WAS REPROGRAMMED AND THE LEAD 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
1	SPRINT QUATTRO SECURE S	IMPLANTABLE TACHY LEAD	LWS	MEDTRONIC PUERTO RICO, INC.	6935

Patients

Seq	Age	Sex	Outcome	Treatment
1	33 YR		Required Intervention	(B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB