MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems Disconnection (1171); Difficult to Interrogate (1331); Loose or Intermittent Connection (1371); Failure to Advance (2524); Device Displays Incorrect Message (2591)

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

Event Date 07/01/2014

Event Type  malfunction  

Event Description

It was reported that the unused generator could not be interrogated prior to surgery despite using two programming systems.The first programming system showed the interrogation progress bar but it did not advance any further.A heard reset was performed but the issue did not resolve.The handheld device was confirmed to be unplugged from the power adaptor.The second programming system displayed an ¿unable to open port¿ error message.It was noted that the usb to port connection was loose.The communication issues were confirmed to be not related to the wand battery.Emi is not suspected as other devices have been able to be interrogated.The loose usb to port connection for the tablet device was reported in manufacturer report # 1644487-2014-01875.The unused generator has not been returned to date.Attempts for additional relevant information have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• 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: 3958794
• MDR Text Key: 14877060
• Report Number: 1644487-2014-01874
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/01/2014
• Initial Date FDA Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1