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

Model Number 105

Device Problem Programming Issue (3014)

Patient Problem Weight Changes (2607)

Event Date 03/01/2014

Event Type  Injury  

Event Description

It was reported that the vns patient developed apathy and anorexia after his device was first programmed on.The physician is looking at multiple possible etiologies.The patient has pituitary dysfunction due to six brain surgeries for a pinealoma.The patient¿s device was programmed off during an office visit on (b)(6) 2014.Further follow-up revealed that the patient was last seen on (b)(6) 2014.At that time, it was noted that the patient had gained weight and had improved mental status since the device was programmed off.The patient was previously overweight and had been very talkative.Clinic notes from the patient¿s office visit stated that the patient¿s issues were likely not related to vns as the patient¿s device settings were very low.It was also noted that the patient had recently moved, and this may have had an effect on the reported events.The patient¿s device was to remain programmed off until the patient¿s next office visit.

• 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: 3792218
• MDR Text Key: 4475122
• Report Number: 1644487-2014-01180
• 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
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2015
• Device Model Number: 105
• Device Lot Number: 3811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 46 YR