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

Model Number MODEL 250

Device Problems Bent (1059); Failure to Interrogate (1332); Loose or Intermittent Connection (1371)

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

Event Date 10/30/2014

Event Type  malfunction  

Event Description

It was reported that the physician's programming system was unable to interrogate a known working generator.Troubleshooting was performed which identified that the physician's programming system was found to not interrogate.The physician was provided a new programming system and the handheld and wand were returned for analysis.Analysis of the handheld was completed on (b)(4) 2014.During the analysis an intermittent power connection associated with the serial cable was identified.The cause for the anomaly is associated with a bent serial cable plug leaf spring that prevented electrical contact with the ac adapter barrel connector.The cause for the bent spring is unknown, but is most likely associated with mishandling of the device.Analysis of the flashcard was completed on (b)(4) 2014.No anomalies associated with flashcard software were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.Analysis of the wand was completed on (b)(4) 2014.The returned battery was depleted and was not the recommended type per labeling (battery type labeling recommends alkaline).After the battery was substituted, the programming wand performed according to functional specifications.

Manufacturer Narrative

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

• 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: 4392435
• MDR Text Key: 21833236
• Report Number: 1644487-2015-03544
• 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: Physician
• Type of Report: Initial
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• 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: 1075851
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1