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

Model Number 102

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Discomfort (2330)

Event Date 10/30/2006

Event Type  Injury  

Event Description

Initially, it was reported that the patient had reached out to the surgeon requesting to have the device explanted.It was later reported that the patient reports a significant amount of gi distress and feels that it is linked to vns.It was reported that the patient feels that the lead around the nerve is causing or contributing to his chronic gi upset.It was reported that the physician does not confirm nor deny the patient's allegations, but feels that the patient feels distressed about having vns implanted and has no objections to removing the device.The patient underwent vns explant.The explanted device has not been received to date.

Event Description

Additional information was received from the medical professional that the patient¿s gi issues were first observed since the vns was programmed on.There was no known history of gi issues or risk factors that makes patient more susceptible to gi issues prior to vns implant.The medical professional believed that the gi issues are likely related to vns stimulation/implantation.Attempts for the diagnostic test results were made but the patient's vns was reported to be programmed off prior to the patient¿s explant.Patient¿s vns explant was not planned to preclude a serious injury.

Manufacturer Narrative

Manufacturer Narrative

(b)(4).

• 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: 4402333
• MDR Text Key: 5369908
• Report Number: 1644487-2015-03578
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2007
• Device Model Number: 102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 01/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR