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

Model Number MODEL 250

Device Problems Loose or Intermittent Connection (1371); Charging Problem (2892)

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

Event Date 01/15/2015

Event Type  malfunction  

Event Description

The design history record was reviewed and the device passed all manufacturing and quality control inspection steps prior to shipment.No anomalies observed in review of the device history record.

Event Description

Product analysis for the tablet was completed and approved on 04/06/2015.An analysis was performed on the returned tablet and the reported allegation was not verified.No anomalies associated with the main battery were identified during the analysis.During the analysis, it was identified that the tablet could not charge the main battery, and as a result was also not able to be powered using the main battery.The cause for the identified anomaly is associated with a loose battery cable to the motherboard.Once the cable was reseated, no further anomalies were identified during the analysis.

Manufacturer Narrative

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

Event Description

It was reported that the tablet device would not hold a charge for more than an hour.While plugged in to the power adaptor, the charging indicator was on and the tablet worked fine.The tablet device was returned to the manufacturer for analysis which identified that the tablet could not charge the main battery, and as a result was also not able to be powered using the main battery.The cause for the identified anomaly is associated with a loose battery cable to the motherboard.Once the cable was reseated, no further anomalies were identified during the analysis.

Manufacturer Narrative

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

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4494098
• MDR Text Key: 5630357
• Report Number: 1644487-2015-03780
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 10.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1