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

Model Number MODEL 250

Device Problems Defective Component (2292); Device Operates Differently Than Expected (2913)

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

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that the physician's programming handheld is not working correctly.It was reported that the battery cover is bowed out and will not close correctly causing a message to pop up about closing the latch.The physician was provided a new programming handheld.The faulty handheld is expected to be returned for analysis, but has not been received to date.

Event Description

The suspect handheld product information was obtained.The handheld was later received by the manufacturer for analysis.However, analysis has not been completed to date.Review of the handheld device history records confirmed that all quality inspections were passed prior to distribution with no non-conformances.

Event Description

An analysis was performed on the returned handheld and the reported allegation was verified.A visual analysis of the handheld was able to verify that the main battery was swollen.During the analysis, it was also 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 with the handheld or software.

• 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: 5780434
• MDR Text Key: 49855341
• Report Number: 1644487-2016-01543
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2016

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
• Device Lot Number: 1075663
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/01/2016; 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1