MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problems Failure to Interrogate (1332); Device Displays Incorrect Message (2591); Application Program Problem (2880); Battery Problem (2885)

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

Event Date 04/02/2014

Event Type  malfunction  

Event Description

The physician reported that the programming system issue has resolved and no further issues have been observed.The physician reported that the patient does not have an appointment scheduled until (b)(6) 2014 and that the patient has not had any complaints or concerns.

Event Description

It was reported that the patient's device was unable to be interrogated.The physician performed troubleshooting and identified that an error message indicated "procedure failed, error in communication".The physician's office indicated that this is the first occurrence that this message had been received.The physician ensured that the programming system was not plugged into the wall and that all cables were secure; however, the issue still occurred.The physician requested that a company representative come troubleshoot the programming system.A company representative performed troubleshooting on the physician's handheld.It was reported that the handheld was not recognizing the new version software that was installed in the handheld.The company representative performed and hard reset and loaded the new software successfully.It was also determined that the wand battery was depleted, which was replaced.The handheld and wand successfully interrogated and performed diagnostics on demo generators.The patient has not been seen again since the troubleshooting on the programming system; therefore, it is unknown whether or not the patient's generator is now able to be communicated with.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• 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: 3787195
• MDR Text Key: 4394783
• Report Number: 1644487-2014-01181
• Device Sequence Number: 1
• Product Code: MUZ
• 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
• Report Date: 04/02/2014

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: Lay User/Patient
• Device Expiration Date: 05/31/2011
• Device Model Number: 102
• Device Lot Number: 2429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/01/2014
• Initial Date FDA Received: 05/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2009
• 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
• Patient Age: 45 YR