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 Problems Apnea (1720); Muscle Spasm(s) (1966); Neck Pain (2433)

Event Date 11/17/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient reported that when she was last titrated up she began to wake up and feel like she had stopped breathing in her sleep.She said that had never happened to her before, she wasn't a snorer, and that her family didn't have a history of this symptom.In addition, she began to hum very loudly in her sleep, she began to hear tapping sounds in her throat every few seconds and she felt like she could feel someone lightly tapping in her throat.She also felt that her throat was tightening during stimulation.She described these sensations as having some pain associated.She indicated that her device was turned back down but that this hadn't helped her much.No further relevant information has been received to date.

Event Description

When follow up was performed regarding the patient's potential sleep apnea and her hoarseness, the physician's office indicated that they hadn't been aware of these issues previously.No further relevant information has been received to date,.

• 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: 6820533
• MDR Text Key: 83647405
• Report Number: 1644487-2017-04362
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2011
• Device Model Number: 103
• Device Lot Number: 2597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2010
• 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; Required Intervention
• Patient Age: 18 YR