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

Model Number MODEL 250

Device Problem Failure to Charge (1085)

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

Event Date 02/25/2015

Event Type  malfunction  

Event Description

A company representative reported that there is an issue with the handheld power cable port, which is preventing the handheld from charging.It was reported that the cable worked in other handhelds and that other cables produced the same result.A new programming tablet was provided to the company representative.The faulty handheld is expected to be returned for analysis, but has not been received to date.

Event Description

The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative

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

Event Description

Product analysis was completed for the handheld device on (b)(6) 2015.No anomalies associated with either of the 2 returned ac adapters were identified during the analysis.During the analysis it was identified that the handheld would not power on.The cause for the anomaly is associated with damaged handheld sync connector leads to the main pcb.Because of the damage, the handheld was unable to receive power from the ac adapter.The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle.No other anomalies were identified.Product analysis was completed for the software flashcard on (b)(4) 2015.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

• 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: 4632858
• MDR Text Key: 5754164
• Report Number: 1644487-2015-04242
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MODEL 250
• Device Lot Number: 1077283
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2010
• 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