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 Paresis (1998)

Event Date 01/01/2012

Event Type  Injury  

Event Description

The patient had their generator disabled due to unilateral vocal paresis and marked reduction in speech output.Recently the patient elected to have their vns replaced and underwent surgery.This surgery was not for the patient's vocal cord paresis.A programming history review showed that the patient's device had been disabled and the last known diagnostics were with in normal limits.No other relevant information has been received to date.The explanted device have not been received to date.

Event Description

Since the device was implanted initially the family reports that he has talked less and more of a whisper than he did before.The patient does not talk very much and has mental retardation.A series of test with an ent were performed and all came back negative.The family has recently elected to have the device replaced and turned back on due to the seizure control the patient gained with the generator.No other relevant information has been received to date.The explanted product has not been returned 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: 6267938
• MDR Text Key: 65452807
• Report Number: 1644487-2017-03054
• 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: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2012
• Device Model Number: 103
• Device Lot Number: 2688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2010
• 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
• Patient Age: 17 YR