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

Model Number 105

Device Problem Extrusion (2934)

Patient Problems Erythema (1840); Impaired Healing (2378); Fluid Discharge (2686)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Information was received that indicates that the patient's generator had began extruding from his body.The site had become red and liquid was seen around the wound area.The device was then explanted on (b)(6) 2016.The surgeon indicated that the extrusion was due to poor wound healing.No other relevant information has been received to date.

Event Description

The patient's explanted generator was received on 11/01/2016 and is undergoing product analysis, which has not be completed to date.No other relevant information has been received to date.

Event Description

Product analysis was completed on 12/05/2016 for the explanted generator.The generator was able to complete all functional tests with no anomalies identified.

• 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: 6069744
• MDR Text Key: 58919250
• Report Number: 1644487-2016-02407
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: VE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2017
• Device Model Number: 105
• Device Lot Number: 4293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/07/2016
• Initial Date FDA Received: 11/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/21/2016; 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• 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: 19 YR