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

Model Number 302-30

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2017

Event Type  malfunction  

Event Description

Clinic notes reported that a patient was referred for full revision surgery due to high impedance.The high impedance was identified via diagnostic test, which indicated that the device was providing a lower output current than was programmed.The physician requested x-rays of the patient's device.The x-rays were sent to the manufacturer; however, since x-ray viewer software did not accompany the images, the x-rays could not be reviewed by the manufacturer.The patient underwent full revision surgery due to battery depletion and high impedance.The explanted devices were planned for return to the manufacturer, but have not been received by the manufacturer to date.No additional relevant information has been received to date.

Event Description

The explanted lead and generator were received by the manufacturer; however, analysis has not been approved to date.No additional relevant information has been received to date.

Event Description

Analysis was approved on the generator.When received, the data was downloaded from the generator and reviewed.A >25% increase in impedance was observed 6 months prior to explant.Since the impedance values before and after the observed increase indicated high impedance, it is likely the high impedance existed prior to the date that the change was observed.No visual anomalies were identified with the generator.Testing was performed on the internal circuitry of the generator, and the device performed according to functional specifications.Analysis was also approved for the lead.A portion of the lead assembly was returned in one piece, but the electrodes were not returned and thus an assessment cannot be made on that portion of the lead.Five sets of set screw marks were seen on the connector pin providing evidence that proper contact between the lead and generator existed 4 times; one set of the set screw marks was located at the end tip suggesting that the lead connector pin was not completely inserted at one point in time.A lead fracture was not observed in the returned portion of the lead.No additional relevant information has been received to date.

• 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: 6821687
• MDR Text Key: 83686360
• Report Number: 1644487-2017-04375
• 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: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/17/2010
• Device Model Number: 302-30
• Device Lot Number: 1921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2007
• 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: 21 YR