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

Model Number 102

Device Problem Unintended Collision (1429)

Patient Problems Fall (1848); Pain (1994)

Event Date 10/06/2014

Event Type  Injury  

Event Description

It was reported that the surgical intervention was not taken to preclude a serious injury.It is unknown if the patient's pain with device stimulation has resolved as the patient has not been seen by the physician since generator replacement.

Event Description

Additional information was received that the patient has been seizure free for the past two months.

Event Description

It was reported that the vns patient began experiencing painful stimulation from the generator site up to the neck after experiencing a fall.The patient went to the er on (b)(6) 2014 due to intolerable pain and was given pain medication.Clinic notes were received indicating that the patient was referred for surgery although diagnostics showed normal device function at the time.The notes briefly mention that patient¿s painful stimulation.An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2014.The explanted generator was returned to the manufacturer for analysis which concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.The device performed according to functional specifications.Attempts for additional relevant information have been unsuccessful 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: 4243940
• MDR Text Key: 5246354
• Report Number: 1644487-2014-02989
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2014

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: 07/31/2008
• Device Model Number: 102
• Device Lot Number: 016066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 11/11/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/15/2014; 01/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2006
• 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: 30 YR