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

Model Number 105

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

An update was received on 06/16/2016 from clinic notes dated (b)(6) 2016.Notes state that while assessing her vns device, it is obvious that the device has become mobile.It was stated to be turned up on its side when the physician went to assess the settings.An update later stated that since the device migrated, the patient is scheduled for surgery, no replacement.It is unclear if this event is a continuation from the previous migration in 2014 that was confirmed invalid or if this was a new event.

Event Description

The patient underwent a pocket revision on (b)(6) 2016.No device were replaced.The physician was not sure if this migration was related to the events in 2014 or a new event.No known trauma or manipulation was noted.The cause of the migration is unknown.

Event Description

Operative notes from (b)(6) 2014 were received.There is no mention in the notes of the type of suture used.Notes just state "the pocket was enlarged.The new generator was then imbedded into the pocket.Wound was then closed in layers.The deep layer was with a 4-0 vicryl.".

• 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: 5780163
• MDR Text Key: 49123188
• Report Number: 1644487-2016-01538
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2016

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: 10/16/2015
• Device Model Number: 105
• Device Lot Number: 3790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/04/2016; 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2013
• 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: 39 YR