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

Model Number 102

Device Problems Failure to Interrogate (1332); Unexpected Therapeutic Results (1631); Battery Problem (2885)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 09/01/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device could not be interrogated.The physician was able to interrogate other devices successfully with the programming system that day.It was noted that the patient was no longer able to perceive stimulation on-times from her device.The patient¿s device was last interrogated six months ago.A battery life calculation using the available programming history showed 0 years until eri = yes.Attempts for additional relevant information will be made.

Event Description

On (b)(6) 2015 the patient reported that her battery had ¿run down¿ and wanted it to be replaced.Although surgery is likely, it has not occurred to date.

Manufacturer Narrative

Event Description

Clinic notes received for patient's generator replacement referral indicates that the patient¿s generator is dead due to battery depletion.It was also reported that the patient also had a remission of depression since (b)(6) 2014.No known surgical interventions have occurred to date.

• 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: 4338431
• MDR Text Key: 5222314
• Report Number: 1644487-2014-03377
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2007
• Device Model Number: 102
• Device Lot Number: 012407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2005
• 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: 52 YR