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

Model Number 105

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 11/12/2015

Event Type  Injury  

Event Description

It was reported that the patient swiped her magnet and the stimulation was so strong it made her cry.Subsequent device stimulation (normal mode and magnet mode) was painful.The magnet was used to disable the device and the patient was seen by the physician.Device diagnostics were within normal limits and the device was not at end of service.The patient was sent for x-rays.The patient underwent generator and lead replacement due to the painful and shocking stimulation.The explanted devices have not been received for analysis to date.

Event Description

The generator and lead were received for analysis.Analysis of the generator was completed on 01/04/2015.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery showed ifi=no condition.There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

Analysis of the lead was completed on 01/11/2016.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

• 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: 5272254
• MDR Text Key: 32862721
• Report Number: 1644487-2015-06667
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2015
• Device Model Number: 105
• Device Lot Number: 202722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2013
• 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: 27 YR