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

Model Number MODEL 250

Device Problems Break (1069); Crack (1135); Failure to Power Up (1476); Improper or Incorrect Procedure or Method (2017); Charging Problem (2892)

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

Event Date 04/02/2014

Event Type  malfunction  

Event Description

A company representative indicated that the handheld was not holding a charge.It was reported that the handheld was left plugged into the outlet all night and when unplugged the handheld immediately lost the charge.The handheld was plugged into another outlet which did not resolve the issue.A new handheld was provided to the company representative and the handheld and flashcard that would not charge were returned to manufacturer for analysis.Analysis of the handheld was completed on (b)(4) 2014.During the analysis, it was identified that some of the sync cable connector leads were damaged and that some of the solder connections between the sync cable connector leads and the handheld pcb were cracked.Because of the damage, the handheld was unable to receive power from the ac adapter.The cause for the damage to the connector 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.Analysis of the flashcard was received 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.

• 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: 3782117
• MDR Text Key: 20785352
• Report Number: 1644487-2014-01147
• 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
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• 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: 1075226
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2014
• Event Location: Other
• Date Manufacturer Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1