MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Positioning Problem (3009)

Patient Problems Irritation (1941); Pain (1994)

Event Date 10/28/2013

Event Type  Injury  

Event Description

It was reported that the patient had surgery on (b)(6) 2015.The patient¿s spouse reported that the lead was replaced, and the surgeon made a new pocket for the generator to be placed in.It was reported that the generator was not replaced, only repositioned.It was reported that the patient was doing okay.The explanted lead has not been received by the manufacturer to date.

Event Description

The surgeon reported that the patient had been reporting painful stimulation prior to surgery.During surgery on (b)(6) 2015, no obvious insulation breaks were noted, but it was reported that there was fluid and air bubbles inside electrode insulation.

Event Description

It was later reported on (b)(6) 2015 that the patient was scheduled for a lead replacement and generator repositioning surgery.The patient had previously had generator repositioning surgery in (b)(6) 2014 due to irritation at the clavicle area.At that time, surgery was performed for patient comfort reasons.It was later reported in (b)(6) 2015 that the patient continued to feel pain and tenderness at the generator site during weight bearing activity.As the patient is wheelchair bound, she has to use her upper body for wheelchair transfers quite a bit and experiences pain at the generator site with every transfer with weight bearing activity.She also reports feeling a sensation that the generator moves while turning in bed or during exercises in physical therapy.At that time, it was noted that generator placement posteriorly (on the scapular area) might be considered due to the patient¿s pain to reduce chest muscle sensitivity.It was also reported at that time that the patient experienced painful stimulation at the neck if output current is increased above 0.5 ma.As a result, the device was temporarily disabled and turned on again on (b)(6) 2015.However, the neurologist felt this is not a therapeutic level of therapy.The patient was referred for replacement surgery, as it was reported that the patient continues to feel a ¿taser-like¿ sensation at 0.5ma current.Pulse width was adjusted from 250usec to 130usec which reportedly worsened the sensation.The pulse width was then adjusted up to 500usec which again worsened the sensation.The painful stimulation was in the throat, along the jaw line and neck which had reportedly been present since being programmed on three days after implant.The treating physician and patient determined to have the lead completely revised as this sensation has been present since the date that the device was first programmed on.The patient¿s device was turned off until she can have lead revised as the therapeutic level cannot be tolerated and the side effect is too uncomfortable even at 0.5ma.It was reported that a 4.0-maxon suture (absorbable) was used to suture device to tissue.However, the device does move within the pocket and it creates considerable discomfort.The plan was for the patient to discuss with the surgeon to either place the device on the right chest wall or on the upper back.Clinic notes dated (b)(6) 2015 reported that the device was turned off (b)(6) 2014.The patient no longer had the ¿shocking pain¿ in the left neck and throat region.However, she still had pain in the left anterior chest wall due to the generator.On the clinic visit on (b)(6) 2015, the neurologist proceeded with turning the device on to low setting per surgeon request, but the patient still felt the shocking sensation with stimulation.Lyrica was added for the pain management.The surgeon assessed on (b)(6) 2015 that the lead could have been placed on the wrong nerve or the lead insulation could have been damaged.He assessed that the solution for the painful stimulation is revision of the leads.The surgeon recommends lead revision and repositioning the generator in the left chest.The patient was referred for surgery.Diagnostics have reportedly been within normal limits.Although surgery is likely, it has not occurred to date.

Manufacturer Narrative

Event Description

Analysis was completed on the explanted lead.A punctured opening was identified in the outer silicone tubing.Although difficult to state conclusively this condition was most likely caused during manipulation of the lead at implant/ explant related to surgeon use and not a device malfunction.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious opening was noted on the inner silicone tubing other than the end of the returned lead.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Event Description

A vns implant card was received reporting that the patient had lead replacement surgery on (b)(6) 2015 due to "lead discontinuity, electrode failure." the patient's spouse reported that they learned that the lead wiring continued bubbles and/or other irregularities under the coating.Good faith attempts for additional, relevant information from the surgeon have been unsuccessful to date.The explanted lead was received by the manufacturer for analysis.However, analysis has not been completed to date.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4566036
• MDR Text Key: 5749703
• Report Number: 1644487-2015-04032
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2015
• Device Model Number: 105
• Device Lot Number: 3754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2013
• 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: 30 YR