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

Model Number MODEL 250

Device Problems Failure to Interrogate (1332); Loss of Power (1475); Difficult or Delayed Activation (2577)

Patient Problem No Patient Involvement (2645)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

It was reported that the handheld device would take a long time to perform interrogations and would only work when plugged into the power adaptor.When it was unplugged, the handheld would power off.The handheld device, software flashcard, and programming wand have been returned to the manufacturer where analysis is currently underway.

Event Description

Analysis of the returned devices was completed.No anomalies associated with programming wand and flashcard software were identified during analysis.The programming wand and flashcard software performed according to functional specifications.Analysis identified that handheld was unable to charge the main battery.The cause for the anomaly is associated with broken solder connections on the handheld main board.No anomalies associated with the main battery were identified during the analysis.

Manufacturer Narrative

Manufacturer Narrative

Date of this report; corrected data: the previously submitted mdr inadvertently did not provide the correct date for this field.This report is being submitted to correct this data.Date received by manufacturer; corrected data: the previously submitted mdr inadvertently did not provide the correct date for this field.The date for this field should have been (b)(6) 2015.This report is being submitted to correct this data.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.Date of this report; corrected data: clarification was received stating the correct date for this field in the initial mdr is 03/30/2015.The previously submitted mdr should not have been submitted as the date to this field did not require a correction.Date received by manufacturer; corrected data: clarification was received stating the correct date for this field in the initial mdr is 03/30/2015.The previously submitted mdr should not have been submitted as the date to this field did not require a correction.

• 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: 4662441
• MDR Text Key: 5609274
• Report Number: 1644487-2015-04379
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• 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: 1075226
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1