MAUDE Adverse Event Report: CYBERONICS PULSE GENERATOR MODEL 106

Model Number 106

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

Patient Problems Aspiration/Inhalation (1725); Dysphagia/ Odynophagia (1815)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

Udi-no.: (b)(4).

Event Description

It was reported that vns patient has swallowing problems.The patient has to be fed with liquid foods.However, the patient did benefit from vns therapy as the patient is now almost seizure free.Phone call received from the patientfather indicated that the swallowing started on (b)(6) 2015 and unknown if this is associated with vns stimulation.The patient was hospitalized from (b)(6) 2016 due to epilepsy seizures and from (b)(6) 2016 due to silent aspiration.It was also reported that the tube placed for the patient was initially made to dose the medicaments, this was later also used to fed the patient due to the swallowing difficulties.It was also reported that patient was followed up by ent doctor and logopedist for his health state.

• Brand Name: PULSE GENERATOR MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 6081301
• MDR Text Key: 59283797
• Report Number: 1644487-2016-02562
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/13/2017
• Device Model Number: 106
• Device Lot Number: 4275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2015
• 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): Hospitalization
• Patient Age: 49 YR