LEAD MODEL UNK

MDR report key: 3961986 · Received July 28, 2014

Report

Report Number: 1644487-2014-01878
Event Type: Malfunction
Date Received: July 28, 2014
Date of Event: January 1, 1996
Report Date: June 30, 2014
Manufacturer: CYBERONICS, INC.
Product Code: LYJ
PMA / PMN Number: P970003
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NO
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

Description of Event or Problem · 1

A POSTER DATED "LEAD MALFUNCTION IN VAGUS NERVE STIMULATION: CLINICAL EFFECT, DIAGNOSIS, AND OUTCOME AFTER LEAD REVISION " WAS SEEN. THE ARTICLE NOTED THAT OF 514 PATIENTS IMPLANTED WITH VNS FROM 1996-2013, 35 PATIENTS UNDERWENT SURGICAL VNS REVISION DUE TO SUSPECTED LEAD MALFUNCTION. THE RESULTS SHOWED: 27/35 PATIENTS REPORTED CLINICAL WORSENING (MFR. REPORT # 1644487-2008-00976 PREVIOUSLY REPORTED ONE OF THESE EVENTS); 2/35 PATIENTS REPORTED SIDE EFFECTS (MFR. REPORT #S 1644487-2007-01566 AND 1644487-2008-02680 PREVIOUSLY REPORTED BOTH OF THESE); 6/35 PATIENTS HAD HIGH IMPEDANCE DETECTED DURING ROUTINE VNS TESTING (MFR. REPORT #S 1644487-2009-01872, 1644487-2011-02797, 1644487-2011-02799, 1644487-2011-02810, 1644487-2013-02450, AND 1644487-2013-03160 PREVIOUSLY REPORTED THESE). THIS REPORT HOUSES THE REMAINING 26 PATIENTS WITH REPORTED CLINICAL WORSENING. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN PERFORMED, BUT HAVE BEEN UNSUCCESSFUL TO DATE.

Description of Event or Problem · 1

IT WAS REPORTED THAT A LINK IS SPECULATIVE OF THE LEAD BREAK AND CLINICAL WORSENING, BUT THAT LEAD BREAK IS THE MOST PROBABLE CAUSE. IT WAS REPORTED THAT A STUDY WILL ADDRESS THESE ISSUES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
437760	LEAD MODEL UNK	LEAD	LYJ	CYBERONICS, INC.	NI	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention