MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Pain (1994); Seizures (2063); Therapeutic Response, Decreased (2271); No Code Available (3191)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that a patient fell during a seizure that was caused by stress and hit her neck on a table.The patient reported that her generator migrated up towards her collarbone.The company representative saw that the generator was in a position that is commonly placed by surgeons.The patient did have a large bruise on her neck, from under the chin down to the bottom of the neck.Diagnostics were performed, which were within normal limits.X-rays were performed, and they showed that the generator was situated near the left armpit of the patient.The surgeon who placed the generator saw the x-rays, and he stated that the generator was in a place that would be considered normal for how he implants generators.The patient did have a circular bruise about 2 inches more medial than where the generator was observed to be in the x-rays.The location of the bruise is where the patient claimed that the generator was prior to the fall.The patient was referred for revision surgery to ensure the correct placement of the generator.No surgical intervention has occurred to date.Attempts for further information were unsuccessful to date.

Event Description

The physician did believe that the cause of the bruise was from the generator being displaced laterally from the fall.Pocket revision surgery was planned due to the migration of the generator.However, the patient saw her neurologist again instead of going to see the surgeon.The neurologist decided that the generator was in a normal position, which was previously confirmed by the surgeon, and would not require surgery.

Event Description

Clinic notes were received for the patient's appointment with the physician.The patient's generator was displaced and was painful, causing the patient to have reduced ability to mover her left shoulder and arm.The physician stated that the displacement was traumatic (due to a fall from the year before), and the pain in the left armpit and chest started the past few months.The patient also could feel the generator moving towards the axilla.The physician noted that the lead was not prominent before, but now he could see the lead clearly as it was being pulled on by the generator migration.The physician referred the patient for surgery to get a new generator and fix the migration.No surgical intervention has occurred to date.

Event Description

The patient had generator replacement surgery due to migration/pain.The device was explanted by the hospital.Therefore, no analysis could be performed.

• 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: 5337448
• MDR Text Key: 34743287
• Report Number: 1644487-2015-06871
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/10/2017

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: Lay User/Patient
• Device Expiration Date: 10/15/2014
• Device Model Number: 103
• Device Lot Number: 202298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/01/2016; 03/14/2017; 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2012
• 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: 41 YR