MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Low Battery (2584)

Patient Problems Paralysis (1997); No Code Available (3191)

Event Type  Injury  

Event Description

The patient reported that he had vocal cord paralysis, but didn't know when he reported that he had been yelling and then his voice was hoarse and he began coughing.He said that winter was when the issues began.He went to a vocal therapist who fixed the issue but then the most recent winter, the issues began again.He said that his vns was dead and appeared to attribute the vocal cord paralysis to a depleted vns battery.In clinic notes from (b)(6), it was indicated that the patient reported a buzzing feeling in the neck.The physician also noted that the patient had had voice hoarseness for years that was potentially related to the vns.The vns was interrogated and it gave a warning message that the battery was low.The patient's generator was replaced due to battery depletion, but the explanted product has not been received to date.No further relevant information has been received to date.

Event Description

It was reported that the explanted generator was discarded.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 7385632
• MDR Text Key: 103965370
• Report Number: 1644487-2018-00486
• 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: 04/27/2018

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: 09/12/2015
• Device Model Number: 102
• Device Lot Number: 202941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: 04/04/2018
• Supplement Dates FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2014
• 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