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

Model Number 105

Device Problem Pocket Stimulation (1463)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient had an infection, which was first observed, on (b)(6) 2016.The patient's family had noted on (b)(6) 2016, prior to a normal scheduled follow-up visit on (b)(6) 2016, that they had observed some swelling and the generator implant location.The infection was confirmed on (b)(6) 2016 at the follow-up appointment and the patient had a chest ultrasound due to the infection on (b)(6) 2016.The patient underwent a full explant surgery on (b)(6) 2016.It was noted prior to surgery on (b)(6) 2016 that there was actually wound dehiscence which had occurred between (b)(6) 2016 and the surgery date.It was noted the reason for the infection is believed to be the fact that the generator was implanted in the axillary region and the patient is in a wheelchair and the sweat may be a contributing factor to the cause of the infection.Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution.

Event Description

The explanted generator and lead were received by the manufacturer for analysis.Product analysis is expected; however, it has not been completed to date.

Event Description

Product analysis (pa) for the returned generator and lead was completed.The allegation of infection was noted to be beyond the scope of the activities performed within the pa laboratory environment.However, potential contributing factors to this condition were considered/evaluated and none were found to exist.The generator diagnostics were as expected for the programmed parameters.The electrical test showed the generator performed according to functional specifications.There were no performance or any other types of adverse conditions found with the generator.Other than typical wear and explant related observations, no other anomalies were identified with the returned portion of the lead.Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not be made on that 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: 6055616
• MDR Text Key: 58353581
• Report Number: 1644487-2016-02467
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/05/2017
• Device Model Number: 105
• Device Lot Number: 4264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 17 YR