MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-30

Device Problems Fracture (1260); High impedance (1291)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 05/04/2017

Event Type  malfunction  

Event Description

It was reported that high impedance was observed on the patient¿s vns system.The treating physician did not turn off the vns at that time due to patient request.It was later reported that the patient¿s device was disabled prior to surgery because he could not swallow very well.The patient¿s surgeon performed a ct and x-ray of the system and reportedly could not identify a lead fracture.The patient¿s lead replacement surgery was completed.Within the surgery, a test resistor was used on the generator, which resulted in normal impedance in the diagnostic test results.The lead was replaced, and the high impedance resolved.The explanted lead has not been received by the manufacturer to date.No additional pertinent information has been received to date.

Event Description

The explanted lead was received by the manufacturer and is undergoing product analysis.The patient¿s operative reported was received and reviewed by the manufacturer.The vns system was verified to show high lead impedance before an incision was made.The generator was then disconnected, reconnected, and interrogated.The result again showed high impedance.Based on the operative report alone, it is not known if a diagnostic test was performed after the lead pin was reinserted.The generator was then removed, and a diagnostic with the test resistor was within normal limits.Visual inspection by the surgeon did not yield observations of fractures in the lead.Three x-ray images with an ap view of the neck and chest and lateral view of the neck were reviewed by the manufacturer.The generator was placed normally per labeling.The lead pin was visualized passed the connector block.The feedthru wires appeared to be intact.The lead electrodes appeared to be appropriately placed per labeling.No gross lead discontinuities were observed.A potential sharp angle was identified in the lateral neck view; however, it could not be verified to be part of the lead body or a likely sharp angle in comparisons with the ap view.The generator did not appear to obscure any section of the lead.Due to the quality of the images and overlaying body structures, the lead at the connector pin could not be fully assessed.No additional pertinent information has been received to date.

Event Description

Product analysis was completed on the returned lead portion.Note that a portion of the lead assembly was not returned for analysis.Therefore, a complete evaluation could not be performed on the entire lead.The condition of the returned lead portion was consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The set screw marks found on the lead connector pin provide evidence that a good mechanical and electrical connection was present at one point in time.Continuity checks of the returned lead portion were performed, and no discontinuities were identified.Based on the findings, there is no evidence of discontinuities in the returned portion of the device that contributed to the high impedance.Note that since a portion of the lead was not returned for analysis, an evaluation could not be made on that portion of the lead.

• Brand Name: LEAD MODEL 302
• 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: 6599862
• MDR Text Key: 76241612
• Report Number: 1644487-2017-03895
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/17/2004
• Device Model Number: 302-30
• Device Lot Number: 6575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2002
• 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 Age: 39 YR