MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problem Unspecified Infection (1930)

Event Date 04/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient's devices were explanted less than a month from initial implant on (b)(6) 2016 due to infection.Patient is on a 6-8 week antibiotic therapy to clear infection.A review of device history records showed that both the lead and generator were sterilized prior to distribution.

Event Description

Additional information was received that the patient is experiencing hoarseness and coughing which began shortly after the explant surgery.It was initially thought to be bronchitis, but they now believe it to be related to the explant surgery.The patient has been referred to see an ent to assess the adverse events.Patient's hoarseness and coughing had not resolved and patient was provided medication for bronchitis and reflux.Patient saw a pulmonologist on (b)(6) 2016 who stated that the patient developed acute bronchitis.The cause of the bronchitis is unknown.Patient had a pre-existing diagnosis of asthma prior to implant surgery.

• Brand Name: PULSE GEN MODEL 103
• 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: 5659628
• MDR Text Key: 45311891
• Report Number: 1644487-2016-01042
• 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,Followup
• Report Date: 05/03/2016

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: 08/08/2016
• Device Model Number: 103
• Device Lot Number: 203722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2016
• 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