FDA Adverse Event Malfunction Summary report: N

EVERA XT DR

MDR report key: 3990864 · Received August 8, 2014

Report

Report Number: 3004209178-2014-14380
Event Type: Malfunction
Date Received: August 8, 2014
Date of Event: May 16, 2014
Report Date: May 16, 2014
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LWS
PMA / PMN Number: P980016
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

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. PRODUCT EVENT SUMMARY: THE ACTUAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED AN AUDIBLE ALERT SOUND. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. CONCOMITANT MEDICAL PRODUCTS: 5076-45 LEAD, IMPLANTED (B)(6) 2014. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THREE DAYS POST IMPLANT, THE PATIENT CAME INTO THE CLINIC INDICATING THAT THE DEVICE WAS MAKING A TONE. DURING THE VISIT, THE PATIENT INDICATED THAT THE TONE HEARD WAS THE TONE WHEN THE MAGNET IS APPLIED. THE PATIENT'S CELL PHONE WAS NOTED TO BE IN THE POCKET ON THE SAME SIDE AS THE DEVICE AT LEAST ONE OF THE TIMES THAT THE PATIENT HEARD THE TONE, BUT THE PHONE WAS NOT IN THE POCKET AT LEAST ONE OTHER TIME. THE DEVICE 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
470848	EVERA XT DR	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER	LWS	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	DDBB1D4

Patients

Seq	Age	Sex	Outcome	Treatment
1	00052 YR			6947M55 LEAD