MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Pain (1994); Hypoesthesia (2352)

Event Date 09/16/2018

Event Type  Injury  

Event Description

It was reported from the physician that the patient was admitted to the hospital for symptoms of voice changes and neck pain and tingling.The doctor stated that it started 5 days prior and the patient came to the emergency room for the symptoms.The doctor asked what generator the patient had as he was unable to interrogate the patient.He later stated that everything resolved but it is unclear exactly what this means.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7970413
• MDR Text Key: 123865961
• Report Number: 1644487-2018-01840
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2017
• Device Model Number: 105
• Device Lot Number: 203380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2015
• 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: 50 YR