MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Fracture (1260); Connection Problem (2900)

Patient Problem Chest Pain (1776)

Event Date 10/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Manufacturing report # 1644487-2016-02688 houses the reports of lead fracture, painful stimulation and device disablement that was also reported.Information was received that the patient had chest pain which the patient¿s physician attributed to the presence of the device.The patient then elected to consult a surgeon regarding the pain.The surgeon chose to perform exploratory surgery to determine the cause of the patient¿s pain.The surgeon determined that the patient¿s subcutaneous pocket was lying over a muscle and elected to move the pocket more medially to reduce the patient's pain.The surgeon also tested the insertion of the pin in the header of the generator and found that there was an adequate connection present.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 6120637
• MDR Text Key: 60657801
• Report Number: 1644487-2016-02598
• 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
• Report Date: 10/31/2016

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: 12/08/2017
• Device Model Number: 106
• Device Lot Number: 203837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• 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: 46 YR