PROGRAMMING SOFTWARE

MDR report key: 2895465 · Received January 3, 2013

Report

Report Number: 1644487-2013-00036
Event Type: Malfunction
Date Received: January 3, 2013
Date of Event: January 18, 2005
Report Date: December 5, 2012
Manufacturer: CYBERONICS INC
Product Code: LYJ
PMA / PMN Number: P970003
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PROGRAMMING HISTORY WAS REVIEWED.

Description of Event or Problem · 1

A REVIEW OF THE PATIENT'S PROGRAMMING HISTORY FOUND THAT THE PATIENT'S SETTINGS WERE CHANGED UNINTENTIONALLY TO SETTINGS INDICATIVE OF AN INCOMPLETE DIAGNOSTIC TEST. HOWEVER, SYSTEM AND NORMAL MODE DIAGNOSTIC TESTS PERFORMED ON THAT DAY WERE WITHIN NORMAL LIMITS. SEVERAL MAGNET MODE DIAGNOSTICS WERE ALSO PERFORMED ON (B)(6) 2005 WHICH WENT INTO STANDBY. WHILE THE PATIENT'S OUTPUT CURRENT WAS ADJUSTED FROM 0MA TO 1.0MA IN THE SAME OFFICE VISIT, THE OFF TIME WAS LEFT AT 60 MIN WHICH GAVE THE PATIENT AN INEFFICACIOUS DUTY CYCLE. THE OFF TIME WAS NOT ADJUSTED BACK TO 5 MINUTES UNTIL THE (B)(6) 2005 VISIT IT WAS ALSO NOTED MULTIPLE TIMES THAT THE PATIENT'S SETTINGS WERE PROGRAMMED TO 0MA THEN BACK TO THE ORIGINAL SETTINGS WITHIN AN OFFICE VISIT. ON ONE SUCH OCCASION, THE PATIENT WAS INITIALLY INTERROGATED ON (B)(6) 2012 AND FOUND TO BE AT 0MA OUTPUT CURRENT AND MAGNET OUTPUT CURRENT, EVEN THOUGH THE PATIENT HAD LEFT THE PRIOR VISIT OF (B)(6) 2012 PROGRAMMED TO 2.25MA OUTPUT CURRENT AND 2.5MA MAGNET OUTPUT CURRENT. IT IS POSSIBLE THERE IS MISSING DATA BETWEEN THESE TWO VISITS WHICH ACCOUNTS FOR THE CHANGE IN SETTINGS. NO OTHER ANOMALIES WERE NOTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2408	PROGRAMMING SOFTWARE	PROGRAMMING SOFTWARE	LYJ	CYBERONICS INC	MODEL 250	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	40 YR