PROGRAMMING SOFTWARE

MDR report key: 3955190 · Received July 24, 2014

Report

Report Number: 1644487-2014-01861
Event Type: Malfunction
Date Received: July 24, 2014
Date of Event: June 26, 2014
Report Date: June 26, 2014
Manufacturer: CYBERONICS, INC.
Product Code: LYJ
PMA / PMN Number: P970003
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: ND, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE TABLET WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE TABLET. AN ANALYSIS WAS PERFORMED ON THE RETURNED TABLET AND THE REPORTED ALLEGATION WAS NOT VERIFIED. NO SOFTWARE ANOMALIES ASSOCIATED WITH THE TABLET WERE OBSERVED DURING THE ANALYSIS. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE TABLET WAS UNABLE TO DISPLAY AN IMAGE. THE CAUSE FOR THE ANOMALY IS ASSOCIATED WITH A DEFECTIVE DISPLAY. ONCE THE DISPLAY WAS REPLACED WITH A KNOWN GOOD DISPLAY, NO FURTHER ANOMALIES WERE IDENTIFIED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PHYSICIAN'S PROGRAMMING TABLET HAD A WHITE BLACK SCREEN. THE DEVICE WAS POWERED OFF, BUT UPON RESTART THE SCREEN REMAINED BLANK. THE TABLET WAS CONFIRMED TO BE FULLY CHARGED AND IT WAS REPORTED THAT THE TABLET HAD NOT BEEN DROPPED RECENTLY. THE PHYSICIAN'S OFFICE WAS PROVIDED A NEW PROGRAMMING TABLET. THE PREVIOUS TABLET IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT BEEN RECEIVED TO DATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
434235	PROGRAMMING SOFTWARE	PROGRAMMING SOFTWARE	LYJ	CYBERONICS, INC.	MODEL 250	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1