PROGRAMMING SOFTWARE

MDR report key: 2922427 · Received January 18, 2013

Report

Report Number: 1644487-2013-00189
Event Type: Malfunction
Date Received: January 18, 2013
Date of Event: March 18, 2008
Report Date: December 27, 2012
Manufacturer: CYBERONICS, INC.
Product Code: LYJ
PMA / PMN Number: P970003
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS OF PROGRAMMING HISTORY.

Description of Event or Problem · 1

DURING REVIEW OF THE VNS PATIENT'S PROGRAMMING HISTORY ON (B)(6) 2012 IT WAS DISCOVERED THAT TWO FAULTED SYSTEM DIAGNOSTICS TESTS OCCURRED WHICH CHANGED THE PATIENT'S SETTINGS ON TWO DIFFERENT DATES. ON (B)(6) 2008 A FAULTED SYSTEM DIAGNOSTICS TEST OCCURRED AND NO FINAL INTERROGATION WAS PERFORMED. THE PATIENT THEN PRESENTED AT THE NEXT VISIT ON (B)(6) 2008 WITH THE INCORRECT SETTINGS OF OUTPUT=0MA/FREQUENCY=20HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=60MIN/MAGNET OUTPUT=0MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=30SEC. THE PATIENT WAS THEN REPROGRAMMED TO THE DESIRED SETTINGS. A FEW MONTHS LATER ON (B)(6) 2008 ANOTHER FAULTED SYSTEM DIAGNOSTICS TEST OCCURRED, AGAIN WITH NO FINAL INTERROGATION. ON THE PATIENT'S NEXT VISIT ON (B)(6) 2008 THE PATIENT WAS FOUND AT THE INCORRECT SETTINGS OF OUTPUT=1MA/FREQUENCY=20HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=60MIN/MAGNET OUTPUT=1MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=30SEC. THE PATIENT WAS AGAIN REPROGRAMMED TO THE CORRECT SETTINGS. NO PATIENT HARM HAS BEEN REPORTED TO HAVE OCCURRED DUE TO THESE SETTINGS CHANGES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
28332	PROGRAMMING SOFTWARE	PROGRAMMING SOFTWARE	LYJ	CYBERONICS, INC.	MODEL 250	523498

Patients

Seq	Age	Sex	Outcome	Treatment
1	7 YR