FDA Adverse Event Injury Summary report: N

SPRINT

MDR report key: 2811994 · Received October 31, 2012

Report

Report Number: 2649622-2012-16897
Event Type: Injury
Date Received: October 31, 2012
Report Date: November 14, 2012
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: LWS
PMA / PMN Number: P920015/S13
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
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.

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED TO THE MANUFACTURER; HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED THAT THERE WAS NOISE ON THE LEAD AS THE VENTRICULAR SHORT INTERVAL COUNT V-SIC EQUALED 1450 COUNTS, IN 83.97 DAYS, BETWEEN (B)(6) 2012. OVERSENSING WAS SEEN AS THERE WAS SEVEN VENTRICULAR NST LESS THAN EQUAL TO 210 MS BETWEEN (B)(6) 2012. THERE WAS ALSO FOUR LFP HIGH RATE-NS (NON-SUSTAINED) LESS THAN OR EQUAL TO 185 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2012. THE DATA ALSO REVEALED THAT THE LEAD INTEGRITY ALERT HAD BEEN TRIGGERED AS THERE WAS ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT WAS TRIGGERED FOR THE RIGHT VENTRICULAR LEAD DUE TO OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. 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	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER	LWS	MEDTRONIC PUERTO RICO, INC.	6943

Patients

Seq	Age	Sex	Outcome	Treatment
1	42 YR		Hospitalization\| R	(B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB