ADVISA DR MRI SURESCAN

Report

Report Number: 9614453-2014-01077
Event Type: Injury
Date Received: June 10, 2014
Date of Event: March 11, 2014
Report Date: March 11, 2014
Manufacturer: IPG MFG SWITZERLAND
Product Code: NVZ
PMA / PMN Number: P980035
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: PHYSICIAN

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. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. CONCOMITANT MEDICAL PRODUCTS: A 5086MRI IMPLANTABLE PACING LEAD: (B)(6) 2013. A 990078 ABLATION CATHETER: (B)(6) 2014. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING THE SIXTH ABLATION, WHILE THE DEVICE WAS PROGRAMMED TO AAIR/DDDR MODE, THE CUSTOMER NOTED THAT THE DEVICE STARTED TO PACE UNEXPECTEDLY. THE ABLATION WAS STOPPED. THE DEVICE WAS CHECKED, WITH THRESHOLDS AND SENSING GOOD, BUT THE DEVICE HAD SWITCHED ON THE ATRIAL LEAD DURING THE ABLATION, GOING FROM BIPOLAR TO UNIPOLAR. THE ATRIAL LEAD WAS PROGRAMMED BACK TO BIPOLAR AND THERAPIES WERE PROGRAMMED OFF, AND THE FOLLOWING ABLATIONS DID NOT REPRODUCE THE ISSUE. 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
339730	ADVISA DR MRI SURESCAN	PULSE GENERATOR, PERMANENT, IMPLANTABLE	NVZ	IPG MFG SWITZERLAND	A3DR01

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	4074 IMPLANTABLE PACING LEAD