MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Failure to Power Up (1476); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2015

Event Type  malfunction  

Event Description

It was reported that a physician's handheld was not powering on.The battery appeared to have expanded.No patients were affected, because a backup programmer was used.The handheld was received on 12/22/2015.Analysis has not been completed to date.

Event Description

Analysis was completed on 01/20/2016 for the handheld and the flashcard.During the analysis it was identified that the handheld would not power on.The cause for the anomaly is associated with a swollen main battery.The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld from powering on (this condition can also cause the handheld to power off intermittently).No further anomalies were identified.The flashcard and software performed according to functional specifications.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5337455
• MDR Text Key: 35250357
• Report Number: 1644487-2015-06873
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1