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

Model Number 304-20

Device Problems Fracture (1260); High impedance (1291); Scratched Material (3020)

Patient Problem No Code Available (3191)

Event Date 09/02/2016

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).

Event Description

High impedance was identified on a system diagnostic test on (b)(6) 2016.The generator was programmed off after the high impedance was identified.The patient underwent full replacement on (b)(6) 2016.X-rays were provided to the manufacturer and reviewed.The generator was shown to be properly placed in the left chest as instructed per labeling, the connector pin appeared fully inserted to the connector block, and the feedthru wires appeared intact.The lead appeared to have adequate strain relief as well as tie-downs present to hold the strain relief as instructed in labeling.No portion of the lead was identified behind the generator, and the lead wires appeared intact at the connector pin.Sharp angles were observed in the portion of the lead near the generator.A gross fracture was identified in the lead.The explanted lead and generator have been returned to the manufacturer, but no analysis has been performed to date.

Event Description

The explanted lead and generator were both returned to have product analysis performed.The lead was returned in two portions.During the visual analysis, the outer silicone tubing of both portions appeared twisted and compressed.The connector boot also appeared detached from the connector ring surface.Scanning electron microscopy (sem) was performed on the connector pin quadfilar coil break and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage.The remaining broken coil strands were identified as having extensive pitting which prevented identification of the coil fracture type.Pitting was observed on the coil's surface.Scanning electron microscopy was also performed on the connector ring quadfilar coil break, but extensive pitting prevented identification of the coil fracture type.During the analysis of the second returned portion, a coil break was identified and the sem identified the area as having evidence of a stress induced fracture.Identification of the fracture mechanism could not be made on the remaining broken coil strand due to extensive pitting.Abraded openings were identified on multiple portions of the returned lead through both the outer and inner tubing.Dried remnants of what appeared to be body fluids was found within the inner tubing.The setscrew marks found evidence that at one point in time, a good mechanical and electrical connection was present the explanted generator was returned and product analysis was completed on 10/11/2016.Review of the ram/flash data from the generator showed increased impedance occurred on (b)(6) 2016 and resulted in an increase from 9,541 ohms to 12,377 ohms.The battery voltage was found at 2.956v and approximately 45% of the charge had been consumed.The generator was found as conforming to all functional specifications.

Manufacturer Narrative

Supplemental report #1 inadvertently did not update the event date per the new information identified.

• 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: 5974973
• MDR Text Key: 55897512
• Report Number: 1644487-2016-02181
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2017
• Device Model Number: 304-20
• Device Lot Number: 202521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/05/2016
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/13/2016; 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2013
• 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 Age: 32 YR