MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Human-Device Interface Problem (2949)

Patient Problem Wound Dehiscence (1154)

Event Date 10/07/2015

Event Type  Injury  

Event Description

It was originally reported by the physician the patient had a large infection at the generator site.The patient's lead and generator were explanted and the surgeon noted dehiscence caused by the patient smoking, and not infection.Attempts for additional relevant information have been unsuccessful to date.

Event Description

The generator is expected to be returned for analysis; however, analysis is not relevant to the wound dehiscence as the dehiscence was reported to be due to the patient's smoking.Product analysis, if the generator is received, will be reported in mfr.Report # 1644487-2015-05824.

Manufacturer Narrative

(b)(4).

Event Description

The explanted lead was returned for analysis.It should be noted that only approximately 15cm of the lead was returned, not including the electrode array; therefore, an evaluation could not be performed on the entire lead.Setscrew marks were seen on the connector pin, providing evidence that, at one point in time, proper contact between the setscrew and the lead pin existed.Other than typical wear and explant related observations, no anomalies were identified in the returned portion of the lead.No other additional relevant information has been received to date.

Event Description

A vns implant card was received indicating the patient had been re-implanted with a new vns generator and lead on (b)(6) 2016.

• Brand Name: PULSE GEN MODEL 106
• 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: 5201164
• MDR Text Key: 30386603
• Report Number: 1644487-2015-06337
• 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,Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/20/2017
• Device Model Number: 106
• Device Lot Number: 203439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• 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: 59 YR