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

Model Number MODEL 250

Device Problems Device Stops Intermittently (1599); Difficult or Delayed Activation (2577)

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

Event Date 05/09/2014

Event Type  malfunction  

Event Description

It was reported that the nurse¿s handheld device was not working properly.The handheld device was slow and worked intermittently.The programming wand was recently replaced and suspected to be contributing to the reported issues.The handheld device took a long to interrogate some devices but worked well with others.The handheld device sometimes failed to interrogate.Troubleshooting was performed and determined that the handheld device needed to be replaced.The handheld device has not been returned to date.

Event Description

The handheld and flashcard were received for analysis.Analysis of the handheld was completed on (b)(4) 2014.An analysis on the returned handheld found that the device would not power on using a known good ac adapter.The cause for the anomaly is associated with damaged solder connections to the pcb.Because of the damage, the handheld received power from the ac adapter intermittently.The cause for the damage to the 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.Analysis of the flashcard was completed 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 manufacturing records were reviewed.Review of manufacturing records confirmed that the handheld device passed all functional tests prior to distribution.

• 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: 3847263
• MDR Text Key: 4408579
• Report Number: 1644487-2014-01408
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• 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: 1063525
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1