MAUDE Adverse Event Report: CYBERONICS, INC. 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 07/11/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr?, (b)(4).

Event Description

It was reported that the patient had an infection at both the lead and generator site.The patient was initially implanted approximately a month prior to the report.The manufacturer's device history records were reviewed and it was verified that the lead and generator were sterilized prior to distribution.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

It was reported that the patient's generator and lead were explanted.The patient reportedly had a tuberculosis infection.The patient reported that she went to the er on (b)(6) 2017 vomiting, swelling, and a feeling like she had something "pressing against her trachea." the er told her that her post-operative swelling was normal.The neurologist prescribed iv fluids and zofran.Then, she woke up with purulent discharge from her neck incision and she went to the er on (b)(6) 2017 where she was treated with antibiotics and after 24 hours was referred for explant and transferred via ambulance, she was diagnosed with a postoperative infection and treated.On (b)(6) 2017 they lavaged her device but on (b)(6) 2017 took her to the hospital and explanted her vns.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 6854331
• MDR Text Key: 85593136
• Report Number: 1644487-2017-04439
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

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: 03/01/2019
• Device Model Number: 106
• Device Lot Number: 204061
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/11/2017
• Supplement Dates Manufacturer Received: 09/12/2017
• Supplement Dates FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2017
• 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): Other
• Patient Age: 48 YR