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

Model Number 106

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

Patient Problems Chest Pain (1776); Pain (1994); No Code Available (3191)

Event Date 03/14/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that a generator pocket revision surgery was scheduled for the patient.The patient reported that she felt like there was a little movement within the pocket, so the physician planned to perform exploratory surgery.Follow up with the office of the surgeon showed that the generator movement was first noted by him in an office visit.Review of the operative report from the patient¿s previous generator implant surgery did not show a reference to the generator being sutured within the pocket.In the consult appointment, the surgeon noted that the generator did have some mobility within pocket and moved slightly to the left.It was assessed that the generator was causing left chest and arm pain via physical irritation to the pectoralis and biceps muscles.The patient and caregiver requested the surgeon to move the generator medially.Surgery to reposition the generator was completed as planned.In this surgery, the surgeon placed a non-absorbable suture to secure the generator within the pocket.No additional pertinent 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: 6572484
• MDR Text Key: 75351155
• Report Number: 1644487-2017-03827
• 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
• Report Date: 05/17/2017

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: Health Professional
• Device Expiration Date: 09/15/2018
• Device Model Number: 106
• Device Lot Number: 5044
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2016
• 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): Required Intervention
• Patient Age: 51 YR