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

Model Number 106

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Unspecified Infection (1930); Organ Dehiscence (2502)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient had her vns explanted on (b)(6) 2016 as her incision had broken open.The surgeon was concerned that everything was infected.Originally, it was unknown how the dehiscence occurred; however, it was later found that the patient had fallen on an unknown date, which caused the generator site incision to open.Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution.

Event Description

It was later reported that after the patient's device was explanted she began to have an increase in seizures.The increase in seizures was caused by the loss of therapy as the device was explanted due to the infection.

• 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: 6036101
• MDR Text Key: 57686269
• Report Number: 1644487-2016-02390
• 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
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2018
• Device Model Number: 106
• Device Lot Number: 203837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2016
• 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: 55 YR