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

Model Number 106

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Unspecified Infection (1930); Twiddlers Syndrome (2114)

Event Date 07/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to a company representative by a surgeon that a patient had picked the generator scar site open and went to the er to get it closed again.The patient then picked it open again.Then the patient went to the surgeon to be evaluated, with no intention to have it explanted, however upon evaluation of the site it was severely infected.The surgeon decided to explant the lead and generator on (b)(6) 2016 for concern that the patient will continue to pick at the site even after it has healed again.After speaking with the patient's group home and neurologist it was stated that the vns was working for the patient.The patient had begun to pick on the neck site also, but it was not picked open at the time.The generator site was picked open to the point of re-opening the wound, but the lead was near the surface of the exposed wound, and was not exposed from the wound.The patient was referred to an infectious disease specialist to treat the infection.Review of the manufacturing records for the generator and lead revealed the devices were sterilized prior to distribution.Additional relevant information has not been received 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: 5871569
• MDR Text Key: 51950231
• Report Number: 1644487-2016-01809
• 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: 07/19/2016

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: 03/03/2018
• Device Model Number: 106
• Device Lot Number: 4775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2016
• 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: 43 YR