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

Model Number MODEL 250

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/03/2014

Event Type  malfunction  

Event Description

It was reported that the epileptologist¿s handheld was communicating intermittently.The serial cable was reported to be loose.The handheld frequently travels to different rooms and floors in the hospital.There were no reports of mishandling.Attempts to have the product returned for analysis were made, but the product has not been received to date.

Event Description

It was reported that a new serial cable was provided and the communication issues have persisted.The serial cable has not been received for analysis to date.

Event Description

The handheld serial cable was received for analysis.Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the handheld passed all functional tests prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

An analysis was performed on the returned serial cable and no anomalies associated with communication were identified during the analysis.During the analysis, it was identified that the power cable portion had an intermittent connection.Continuity testing was able to verify an intermittent negative electrical connection in the power connector portion of the hhd serial cable.The cause for the open connection is associated with the serial cable plug leaf spring not making contact with the ac adapter barrel connector.A root cause for the observed leaf spring condition could not be determined during the analysis.

Manufacturer Narrative

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

• 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: 3709805
• MDR Text Key: 4263117
• Report Number: 1644487-2014-00823
• 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,Followup,Followup,Followup
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• 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: 1073167
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1