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

Model Number MODEL 250

Device Problems Failure to Power Up (1476); Device Inoperable (1663); Charging Problem (2892); Electrical Shorting (2926)

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

Event Date 04/08/2014

Event Type  malfunction  

Event Description

It was reported that the physician's handheld will not power on and the charge light does not illuminate when the unit is plugged into the ac power cord.A known working power cord was used and the charge light would still not illuminate and the handheld would not power on.The lock button was not engaged.The physician was provided a new programming tablet and the handheld and flashcard were returned for analysis.Analysis of the handheld was completed on (b)(4) 2014.No anomalies associated with the main battery were identified during the analysis.During the analysis it was identified that the handheld would not power on.The cause for the identified anomaly is associated with an open fuse in the handheld.Once the fuse was replaced no anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.The cause for the open fuse is most likely related with an electrical short caused by the damaged record button on the side of the handheld.No other anomalies were identified.Analysis of the flashcard was completed on (b)(4)2014.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description

Clinic notes were received dated (b)(6) 2014 for the patient.Per the notes, the patient was in to see the physician for a follow up evaluation for seizures.During the visit, the clinic notes stated that the patient's generator was not able to be interrogated due to "technical issues".Through additional investigation, the physician confirmed that these "technical issues" were referring to the reported event of the hand held programming device not being able to power on, which was reported in mfr report # 1644487-2014-01221.

• Brand Name: PROGRAMMING COMPUTER
• Type of Device: PROGRAMMING SOFTWARE
• 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: 3800223
• MDR Text Key: 4526643
• Report Number: 1644487-2014-01221
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• 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: 879565
• Other Device ID Number: VERSION 8.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR