MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problems Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was planned for a generator revision and that the placement of the generator would be moved.Additional information from the physician's office indicated that the reason for the revision was the generator had migrated medially and inferiorly and was causing pain and discomfort to the patient's sternum.The surgery was being done to preclude patient injury.The migration began spontaneously, and the physician had used tichron 30 non-absorbable sutures to anchor the generator in the initial surgery before the migration.Additional relevant information has not been received to date.

Event Description

Additional information was received on 10/28/2016.Per the physician, the repositioning was being done because the generator was rubbing against the patient's manubrium and not being done to preclude serious injury.Information was also received from a company representative on 11/01/2016.He stated that the patient felt that stimulation was being triggered when raising her left arm due to the device migration and has shortness of breath and coughs because of this.Before the revision surgery, the patient saw her physician and the physician lowered the output current to 1.0ma.The change was noted as to have been done for the shortness of breath and cough.The frequency was noted as 15hz, the pulse width as 250 micro seconds, and the off time as 1.1 min.The patient only had 5 autostimulations in the last 102 days prior to the visit.System diagnostics were noted as normal.It is known that stimulation cannot be triggered by the patient's hand or arm movement unless the patient is using a magnet to trigger magnet activation.The device was repositioned on (b)(6) 2016.No additional relevant information has been received to date.

Event Description

It was found out that the patient was in a car crash which is suspected to be the cause of the migration of the device.The adverse events previously reported are stated to have been occurring for some time which predated the accident.Therefore those events appear to be unrelated to the accident and migration of the device.No additional relevant information has been received to date.

Event Description

It was reported that the patient was experiencing a lead pulling sensation which appeared related to the previously migration of the generator.Therefore the physician intended to perform another repositioning surgery where the generator pocket would be moved to the right side of the patient's chest.No additional relevant information has been received to date.No surgical interventions are known to have occurred to date.

Event Description

Additional information was received that the patient complained about discomfort from position of generator and migration of the device from its original position.The patient underwent surgery to reposition the device for these reasons.It is unknown when the device migration and pain began.The surgeon was reported to use non-absorbable suture to secure the generator to the fascia when the device was implanted.Patient manipulation and trauma was denied by patient but considered possible by company representative.The physician does not know the cause of migration as he did tie down the generator each time.The repositioning surgery was not planned to preclude a serious injury.

• Brand Name: PULSE GEN MODEL 106
• 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: 6063772
• MDR Text Key: 58651910
• Report Number: 1644487-2016-02507
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/03/2018
• Device Model Number: 106
• Device Lot Number: 203749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2016
• 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: 41 YR