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

Model Number 103

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Chest Pain (1776)

Event Date 12/08/2014

Event Type  Injury  

Event Description

It was reported that the vns patient was referred for surgery due to chest pain and potential generator migration.No known surgical interventions have occurred to date.

Manufacturer Narrative

Event Description

On 04/29/2016, it was reported that the patient's pain that was first thought to be from the migration (so reported last year) was just recently clarified to be painful stimulation radiating down the jawline with magnet swipes.The patient had not followed up between the report last year and now so this was not known until now.Once the pulse width was adjusted this pain resolved.For the patient's reported migration, he stated there was no reported trauma so they think that the non-absorbable suture may have broken.It was stated that the implanting surgeon does always use non-absorbable sutures.The migration is less painful and more so just an inconvenience as it pops out and moves when she is in different positions.Notes also mention that vns is sticking out.He also noted that the patient's battery was below 50%, so the generator was being replaced prophylactically, though the primary reason for replacement seems to be the migration.Notes state vns moves when she moves left arm and has pain.Clinic notes dated (b)(6) 2016 state that the battery mobility in her chest and its prominence as well as the prominence of the electrode coils in her neck bother her significantly.Inspection of her neck shows fairly prominent positioning of her battery and cervical electrode loops without any skin erosion, erythema, or signs of infection.There is no known cause of the protrusion except normal physiology.

Event Description

Implant card was received on 06/13/2016.The patient underwent generator replacement on (b)(6) 2016.The explanted device was discarded and is unavailable for analysis.

• 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: 4391038
• MDR Text Key: 5432919
• Report Number: 1644487-2015-03534
• 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,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2012
• Device Model Number: 103
• Device Lot Number: 201534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2010
• 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: 37 YR