MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260); Device Contamination with Body Fluid (2317)

Patient Problems Pain (1994); Depression (2361); Neck Pain (2433); No Code Available (3191)

Event Date 08/15/2019

Event Type  malfunction  

Event Description

It was reported that the patient underwent vns generator replacement surgery and it was found that high impedance was present on both the old and new generator.Lead pin insertion troubleshooting was performed and did not resolve the issue.The surgeon stated that prior to the surgery, the impedance was at the higher end of normal impedance at 5,200 o.The patient also reported an intermittent shocking sensation with stimulation.A full revision was not performed at the time and only a new generator was implanted.It was reported previously by the patient that while in a store she felt a tug on her chest like her purse was pulling on her, but she moved her purse and it still happened.She stated that she felt discomfort when she turned her head to the right or pulled it down.She had put the magnet over the generator and still felt the pain and, therefore, did not feel that it occurred with stimulation.Follow up with case management (cm) revealed that the patient stated that she was experiencing a strange feeling when turning her neck to the right or extending her neck.Cm reported that the patient had attended her appointment and was referred for vns replacement surgery as her battery was running down.At the time, per her understanding, the pain was attributed to the battery running down.Clinic notes were received by the manufacturer and indicated that the patient had increasing difficulties with pain along the wire site.The generator was reported as at near end of service and it was noted that the patient's generator needed to be changed.Further follow-up with the physician's office found that surgery wasn't due to the pain, but only due to the low battery.It was stated that the cause of the pain was unknown (and, therefore, unrelated to the vns battery).During attempts at product return for the explanted generator, it was revealed that the facility does not return explanted products.No relevant surgery is known to have occurred to date for the high impedance.No additional relevant information has been received to date.

Event Description

It was reported that the patient had requested that her new vns be programmed on as soon as possible following the replacement surgery as she had experienced an increase in depressive symptoms.The patient underwent a vns lead replacement surgery.The explanted lead has not been received by the manufacturer to date.

Event Description

Lead product analysis was completed.The high impedance allegation was confirmed in the product analysis, or (b)(6), lab.The alleged painful stimulation was beyond the scope of activities performed in the (b)(6) lab; however, the observed discontinuity and exposed conductors due to abraded openings may have been a contributing factor.The lead pulling sensation and increased depression could not be evaluated in the (b)(6) lab.The portion of the lead containing the electrodes was not returned for analysis and, therefore, analysis could not be made as to that portion of the lead.Visual analysis confirmed that the connector pin quadfilar coil appeared to be broken approximately 134 and 137 mm from the end of the connector boot.Scanning electron microscopy, or sem, identified the area on one of the broken coil strands at 134 mm as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting.The remaining broken coil strands were mechanically damaged preventing identification of the coil fracture type with fine pitting on one of the broken strands.Flat spots were observed on the coil surface.Sem identified the area on one of the broken coil strands at 137 mm as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting.The remaining broken coil strands were mechanically damaged preventing identification of the coil fracture type with fine pitting on one of the broken strands.Flat spots were observed on the coil surface.Stimulation was believed to have been present for a certain period of time as evidenced by the pitting.An abraded opening and slice mark were found on the outer tubing and likely provided the leakage path for the remnants of dried body fluids in the outer tubing.Abraded openings on the inner tubing likely provided the leakage path for the remnants of dried body fluids in the inner tubing.Setscrew marks were observed on the connector pin, indicating that a good mechanical and electrical connection was present at one time.Additional setscrew marks were found at the end of the connector pin, indicating that the lead had not been fully inserted at one point.With the exception of the observed discontinuity and the abraded tubing openings, the condition of the returned lead portion was consistent with those typically found following explant.

Event Description

The explanted lead was received by the manufacturer and is pending product analysis.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8978324
• MDR Text Key: 157117191
• Report Number: 1644487-2019-01749
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/12/2007
• Device Model Number: 302-20
• Device Lot Number: 011718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2005
• 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
• Patient Age: 57 YR