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

Model Number 102

Device Problem Low Battery (2584)

Patient Problem Pain (1994)

Event Date 07/07/2014

Event Type  Injury  

Event Description

Additional information was received stating that the patient experienced painful stimulation at the generator site.The generator replacement surgery was reported to be planned for patient's comfort and not to preclude a serious injury.There were no known vns setting changes or trauma to the site that could have caused or contributed to the painful stimulation.No known surgical interventions have occurred to date.

Event Description

An implant card was received indicating that the patient underwent generator replacement on (b)(6) 2014.Attempts made for the return of the explanted product were unsuccessful.The explanted product could not be located by the explant facility.Analysis of the product could not be performed as the product has not been received to date.

Event Description

A surgery referral form was received indicating that the patient was referred for generator replacement because of pain with vns stimulation for 2-3 months.It was noted that the generator is likely nearing end of service.Clinic notes dated (b)(6) 2014 indicate that the patient experiences more auras and will be referred for generator replacement because the generator battery is low.No known surgical interventions have been performed to date.Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

• 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: 4224345
• MDR Text Key: 5115363
• Report Number: 1644487-2014-02920
• 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,Followup,Followup
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2006
• Device Model Number: 102
• Device Lot Number: 011863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2005
• 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 Outcome(s): Required Intervention
• Patient Age: 46 YR