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

Model Number 105

Device Problem Scratched Material (3020)

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)

Event Date 07/11/2014

Event Type  Injury  

Event Description

It was reported that the patient was scheduled for surgical exploration of the generator incision site.It was reported that the patient's wound was not healing poorly.The operative notes dated (b)(6) 2014 note that the patient is an avid hunter and shoots his gun from his left shoulder.It was noted that the generator is implanted on the right side of the patient's chest.It was noted that the patient was admitted to the hospital on (b)(6) 2014 with the medial 1-2 cm of his right chest incision broken down and a small piece of the lead and generator exposed.Further follow-up revealed that cultures were negative for infection.The patient was taken back to the hospital on (b)(6) 2014 because the incision opened up again.The patient underwent generator explant.It was reported that the lead was left in place.The patient requested explant of the device.The surgeon plans to wait a couple of months with the generator removed so the incision can heal and then reimplant another generator.There was no known cause for the impaired incision healing.It was reported that the patient has had good healing prior to vns implant.The explanted generator was discarded; therefore, will not be returned for analysis.

Manufacturer Narrative

Manufacturer Narrative

Conclusions, initial report inadvertently omitted.Conclusion code for device discarded.

Event Description

The patient has decided not to re-implant the vns device for fear of infection recurring.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4051959
• MDR Text Key: 4736793
• Report Number: 1644487-2014-02153
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2015
• Device Model Number: 105
• Device Lot Number: 3813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2013
• 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: 34 YR