EVERA XT VR

MDR report key: 4831592 · Received June 10, 2015

Report

Report Number: 3004209178-2015-10747
Event Type: Malfunction
Date Received: June 10, 2015
Date of Event: April 22, 2015
Report Date: April 22, 2015
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: LWS
PMA / PMN Number: P980016
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY - THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

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 AN ALERT TRIPPED FOR AN IMPEDANCE JUMP ON THE PACE/SENSE PORTION OF THE RIGHT VENTRICULAR LEAD. THE RIGHT VENTRICULAR LEAD ALSO HAD HIGH IMPEDANCE, HIGH THRESHOLDS AND FREQUENT NON-CAPTURE, THOUSANDS OF SHORT INTERVAL COUNTS, NOISE AND A POSSIBLE FRACTURE. DURING CHANGEOUT OF THE DEVICE, NOISE WAS SEEN ON THE PACE/SENSE ELECTROGRAM OF THE NEW DEVICE. THE LEAD TESTED NORMALLY WITH THE ANALYZER. HOWEVER, A SECOND DEVICE WAS ATTACHED TO THE LEAD AND NOISE WAS STILL SEEN. AN ATTEMPT WAS MADE TO REPLACE THE LEAD, BUT THE SUPERIOR VENA CAVA WAS OCCLUDED. THE LEAD WAS LATER EXPLANTED AND REPLACED. THE SECOND 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
376690	EVERA XT VR	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER	LWS	MEDTRONIC PUERTO RICO OPERATIONS CO.	DVBB1D1

Patients

Seq	Age	Sex	Outcome	Treatment
1	00073 YR