MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Skin Erosion (2075)

Event Date 07/08/2015

Event Type  Injury  

Event Description

A report was received indicating that a patient had scratched her surgical incision to the point that the implanted generator was showing.Surgical intervention was undertaken to close the opened incision.The generator was left in the same location and no products were explanted.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received that the patient's generator was removed and that the lead was coiled up and secured in the chest so that it could not migrate.The caregiver reported that the patient had a hard time with the infection (she reported it was so bad that it had traveled up the wire) and an open wound after implant of the vns.Patient had an open wound at the vns incision site.Because of the wound, the patient has been in wound care therapy until the device was removed.The wound was reportedly still present, but was described as an open wound about the size of an eraser that still had fluid discharge.The wound was reported to be almost fully healed.The infection is reported in mfr.Report # 1644487-2016-02286.

• Brand Name: PULSE GEN MODEL 102R
• 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: 4953442
• MDR Text Key: 6037916
• Report Number: 1644487-2015-05354
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

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: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: 102R
• Device Lot Number: 4295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 07/30/2015
• Supplement Dates Manufacturer Received: 07/10/2017
• Supplement Dates FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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: 50 YR