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

Model Number 103

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

Patient Problems Chest Pain (1776); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Tissue Breakdown (2681); No Code Available (3191)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by a company representative that this patient underwent repositioning surgery.The surgeon said that the generator had not been secured by a suture and had fallen.Because of this, the patient was experiencing a lead pulling sensation and subsequent pain.The surgeon repositioned it and sutured the generator in place.The initial implanting surgeon reported that the operating notes did not indicate whether a suture was used to secure the generator during implant.The medical assistant reported that the surgery was mainly for patient comfort.She did indicate that the patient had dark serosanguinous fluid coming out from the incision site post-operatively and that the patient's old incision site was very dark and purple.Pre-operative clinic notes from the surgeon reported that the patient's generator was turned off due to the onset of left sided facial pain and numbness with stimulation that had been occurring for roughly one month.She was experiencing moderate (6/10) pain in her left lateral breast, left lateral neck and left ear but was not having fevers.Reportedly, the patient's skin was tender, firm and red over the vns generator.The notes reported that there was possible inferior migration of the vns generator.Operative notes indicated that the patient underwent repositioning surgery due to generator migration that was causing pain and discomfort.It indicated that the pain was due to the migration of the generator and traction of the lead in neck.During the surgery the surgeon removed a considerable scar from the initial incision site.The generator was repositioned and device diagnostics were within normal limits.Post-operative notes from the surgeon's office indicated that at the two week follow-up appointment there was believed to be some skin breakdown as well as some mild patient-reported discharge.She was referred to a wound clinic for these issues.The company representative reportedly turned the patient back on after the surgery.No further relevant information has been received to date.No known further relevant surgical intervention has occurred to date.

Event Description

It was reported that the patient's generator had extruded, described as "it is hanging out." on (b)(6) 2017, the patient was given antibiotics as her incision site looked red and infected.The next week, on (b)(6) 2017, her generator was exposed and you could see pretty much the whole generator.Therefore the generator was removed the next day.The lead was cleaned, irrigated and then placed back in the pocket.The suspect product has not been received to date.No further relevant information has been received to date.

Manufacturer Narrative

Event problem cds (refer to coding manual), corrected data: supplemental mdr 1 inadvertently did not report patient code (b)(4).

Event Description

Clinic notes from the day prior to generator explant surgery were received that indicated that the patient had been feeling fine until, a week prior began to have pain at the generator site with redness and yellow drainage.The generator had reportedly migrated again and she was given keflex for infection.At this time, the patient was 2 months post-partum of note, the patient's generator had been attached with non-absorbable sutures during her repositioning surgery in (b)(6).Operative notes reported that the patient who had a generator repositioning surgery in (b)(6) (captured in initial report) had redness and swelling at the vns generator site and was placed on antibiotics.The patient's skin eroded and exposed the generator.The patient's wound was classified as dirty.Return of the suspect product is not expected.No further relevant information has been received to date.

Event Description

It was reported that the patient's lead was explanted due to lead-pulling issues with resultant vocal cord issues that were attributed to poor strain-relief, which is captured in mfr report #1644487-2018-00885.It is possible that the strain relief of the lead was affected by the migration.No further relevant information has been received to date.

• 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: 6327892
• MDR Text Key: 67317760
• Report Number: 1644487-2017-03181
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2016
• Device Model Number: 103
• Device Lot Number: 4010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2014
• 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: 24 YR