MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Pain (1994)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the patient was admitted to the hospital for right sided weakness and chest pain and the patient reported that he had had chronic problems with the vns.The patient also reported focal seizures, the last of which was in (b)(6) 2018.Upon follow-up with the patient, it was reported that the patient was experiencing shortness of breath, chest pain, and pain in his throat which had reportedly been occurring on and off for the past few weeks.The on-call physician did not seem to think these symptoms were related to the vns.System diagnostics and normal mode diagnostics were ok.The patient's vns output frequency was lowered from 30 to 20 hz at the direction of the neurologist, who thought this would alleviate some of the symptoms.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 8153856
• MDR Text Key: 130042324
• Report Number: 1644487-2018-02272
• 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: Physician
• Type of Report: Initial
• Report Date: 12/11/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2013
• Device Model Number: 102
• Device Lot Number: 3006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2011
• 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; Required Intervention
• Patient Age: 55 YR