MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Initially, it was reported that the patient developed an infection related to vns and that the physician was working on a plan.It was later reported that the site was not infected, but that the generator had poked through the incision.Further follow-up with the surgeon revealed that the generator was not extruding, but the incision was opening up.The surgeon indicated that he believed the scar retracted and caused the generator to push out with pressure from the way the patient sat in a wheelchair.The patient underwent revision surgery at which time the surgeon moved the generator further back into the pocket.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5542272
• MDR Text Key: 41721407
• Report Number: 1644487-2016-00686
• 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
• Report Date: 03/09/2016

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: 10/15/2017
• Device Model Number: 106
• Device Lot Number: 4587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2015
• 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: 14 YR