MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 304-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Tissue Breakdown (2681); No Information (3190)

Event Date 07/25/2011

Event Type  Injury  

Event Description

It was reported that the patient was referred for a vns removal surgery.The surgeon indicated that the patient¿s caregiver believed that the vns only made things worse for the patient.The exact adverse event was not specified at the time of the report.Follow up with the office of the surgeon showed that the patient had her vns generator and leads removed.The devices were reportedly discarded following explant.No additional pertinent information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

Communication with the office of the treating neurologist showed that the patient was experiencing vns site discomfort.It was assessed to be due to the device presence and was likely occurring since device implant.One of the lead tie-downs appeared to be protruding, and it was assessed that it was due to the patient being small.The explant was believed to be just for comfort and was not to preclude a serious injury.Further information directly from the treating physician showed that the patient¿s lead was eroding through the skin, which was causing discomfort.He was not aware if the skin was broken at the lead site, as the patient¿s site was always either covered up with clothing or medical dressing.Communications with the office of the surgeon showed that all they knew regarding the patient¿s vns was that they were told the patient's mother thought the lead was affecting the patient¿s swallowing, likely from device stimulation.Notes on what was observed at the lead site were not taken, and it could not be recalled what was observed regarding the reported skin erosion.No additional pertinent information has been received to date.

Manufacturer Narrative

The suspect device was inadvertently provided as the generator, and the model#, serial#, lot#, expiration date were inadvertently incorrect as a result.

• Brand Name: PULSE GEN MODEL 103
• 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: 6434719
• MDR Text Key: 70860382
• Report Number: 1644487-2017-03467
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/30/2015
• Device Model Number: 304-20
• Device Lot Number: 201780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2011
• 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: 3 YR