FDA Adverse Event Malfunction Summary report: N

ATTAIN STABILITY

MDR report key: 3861380 · Received June 10, 2014

Report

Report Number: 3002807561-2014-00008
Event Type: Malfunction
Date Received: June 10, 2014
Date of Event: April 3, 2014
Report Date: April 3, 2014
Manufacturer: EOC HEERLEN DISTRIBUTION CTR
Product Code: OJX
PMA / PMN Number: P080006
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: HK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE U.S. 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. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THERE WAS FOREIGN MATERIAL ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. THERE WAS FOREIGN MATERIAL ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. THE TIP SEAL ON THE DISTAL ELECTRODE OF THE LEAD SHOWED EVIDENCE OF BLOOD INGRESSION. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS ATTEMPTED, NOT IMPLANTED. THE GUIDEWIRE COULD PASS THROUGH THE DISTAL LUMEN OF THE LV LEAD THE FIRST TIME, BUT WHEN THE WIRE WAS MOVED OUT AND TRIED TO PASS THROUGH THE DISTAL LUMEN AGAIN, IT COULD NOT. ANOTHER NEW WIRE WAS USED AND WAS UNSUCCESSFUL. A DIFFERENT LEAD WAS USED WITH SUCCESS AND REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
338853	ATTAIN STABILITY	DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE	OJX	EOC HEERLEN DISTRIBUTION CTR	20066

Patients

Seq	Age	Sex	Outcome	Treatment
1