FDA Adverse Event Malfunction Summary report: N

PROGRAMMING SOFTWARE

MDR report key: 3023379 · Received March 27, 2013

Report

Report Number
1644487-2013-00829
Event Type
Malfunction
Date Received
March 27, 2013
Report Date
February 27, 2013
Manufacturer
CYBERONICS
Product Code
LYJ
PMA / PMN Number
P970003
Removal / Correction Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
KS, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

A NEUROLOGIST REPORTED TO OUR CONSULTANT THAT THEIR HANDHELD COMPUTER IS NO LONGER ABLE TO HOLD A CHARGE AND THAT HE HAS ALREADY TRIED TO PLUG IT INTO SEVERAL DIFFERENT WALL OUTLETS WITH THE SAME RESULT. HE STATED THAT THE AC POWER CORD WAS CHECKED VISUALLY AND NOTHING APPEARED TO BE WRONG WITH IT. HE WAS NOT SURE WHEN THIS ISSUE FIRST BEGAN BUT EXPLAINED THAT IT HAS BEEN GOING ON FOR A WHILE. THE HANDHELD WAS RETURNED FOR ANALYSIS. ANALYSIS WAS PERFORMED ON THE RETURNED HANDHELD. NO ANOMALIES ASSOCIATED WITH THE MAIN BATTERY WERE IDENTIFIED DURING THE ANALYSIS. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE SYNC CABLE CONNECTOR ON THE BOTTOM OF THE HANDHELD WAS DAMAGED. BECAUSE OF THE DAMAGE, THE HANDHELD WAS UNABLE TO RECEIVE POWER FROM THE AC ADAPTER. THE CAUSE FOR THE DAMAGE TO THE CONNECTOR IS MOST LIKELY ASSOCIATED WITH MISHANDLING OF THE DEVICE AS IT APPEARS THE CONNECTOR DETENTS ARE NOT BEING COMPRESSED WHEN REMOVING OR MANIPULATING THE SERIAL DATA CABLE, THUS PLACING AN EXTENSIVE AMOUNT OF FORCE ON THE PCB AND ATTACHED CABLE RECEPTACLE. NO OTHER ANOMALIES WERE IDENTIFIED. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
126683 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 1073772

Patients

Seq Age Sex Outcome Treatment
1