MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384)

Patient Problems Seizures (2063); Sleep Dysfunction (2517)

Event Date 10/24/2017

Event Type  malfunction  

Event Description

A report was received indicating a patient was hospitalized for an unknown reason.A representative of the hospital requested a vns replacement as soon as possible.It was later reported via clinic notes that the patient was hospitalized due to increased nocturnal seizure activity and insomnia that had been occurring for 1 month prior to the hospitalization.Per the notes, the patient's mother reported that the seizures were representative of the patient's normal activity, but she believed the nocturnal seizures were more frequent.During the hospital stay, the vns was interrogated and was found to have low battery and high lead impedance.The patient's medications were increased due to vns not working.The patient underwent lead and generator replacement surgery due to the high impedance and low battery.The explanted lead and generator were received by the manufacturer for analysis, but analysis has not been approved for the explanted devices to date.No additional relevant information has been received to date.

Event Description

Analysis approved for the generator.When received, the data was downloaded from the generator and reviewed.Both the pre- and post-change values of the most recent significant change in impedance value indicated high impedance.No surface abnormalities were noted on this device.The pulse generator diagnostics were as expected for the programmed parameters.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.The pulse generator performed according to functional specifications.Analysis was also approved for the returned lead.The lead was returned in two pieces.Two sets of set screw marks were seen on the connector pin providing evidence that proper contact between the set screw and the connector pin existed at least once.Note that since the lead¿s electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Abraded openings were noted in the outer and the inner silicone tubing.A lead break was identified in the positive coil.Microscopy images of the positive coil break show that pitting or occurred at the break location.Also, the positive coil shows what appears to be wear at the break.One strand of the positive coil mate end shows appearance suggesting that a stress-induced fracture occurred due to rotational forces.The overall appearance of the lead is consistent with patient manipulation of the implanted device.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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: 7335824
• MDR Text Key: 102327484
• Report Number: 1644487-2018-00365
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2017
• Device Model Number: 304-20
• Device Lot Number: 3537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2013
• 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: 18 YR