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

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 02/24/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer, additional information: device evaluation is not required for the reported event as it would not be suspected to provide additional relevant information for the reported event.

Event Description

It was reported that a patient had redness, pain, and swelling at her incision site a few weeks after surgery.The site was reportedly fine 7 days after surgery.The patient was administered antibiotics and was reportedly doing a little better.The patient then had an ultrasound performed and her site was still infected after the antibiotics.The manufacturing record for the implanted generator confirmed proper sterilization prior to release for distribution.No known surgical intervention has taken place to date.

• 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: 6484987
• MDR Text Key: 72515776
• Report Number: 1644487-2017-03606
• 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: 04/12/2017

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: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 106
• Device Lot Number: 203928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2016
• 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: 12 YR