MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

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

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

Event Date 09/08/2017

Event Type  malfunction  

Event Description

Report received that a patient's lead was found to be corroded after explant.The reason for the lead explant was initially unknown.The patient was originally scheduled for a generator replacement due to end of service.However, both the lead and generator were replaced.Lead information was illegible due to corrosion covering the labeling.Further information was received that the lead was explanted because it was not compatible with the new generator.System diagnostics had been performed about 4 months prior to explant and results were normal.A review of the device history record indicated all quality inspections were performed and passed prior to release for distribution.The lead was returned and received by the manufacturer.Product analysis has not been completed on the lead to date.No further relevant information has been provided.

Event Description

Product analysis was completed on the lead.Product analysis was completed on the lead.A section of the lead assembly was returned for analysis in two pieces with the lead connector still attached to the pulse generator header.The electrodes were not returned for analysis and an assessment could not be made.Photograph and x-ray images showed that both the marked and unmarked portions were not fully inserted.However, a continuity check was performed and indicated proper contact was still made.It was also found that the lead connectors were incorrectly inserted with the marked (positive) connector in the negative cavity of the pulse generator header.The first portion of the retuned lead was inspected.Three set screw marks were seen providing evidence that proper contact had been made at one time.A single set screw indentation was noted at the end tip of the marked connector pin.Abrasions were noted on the connector boot.White deposits were also noted on the connector boot.Abrasions were noted on the silicone tubing of the marked connector.The positive coil had a spiral/wavy appearance.The second portion of the lead was also visually inspected.Three set screw marks were seen providing evidence that proper contact had been made at one time.The marked connector pin had an opaque appearance in the vicinity of the set screw marks.Abrasions were also noted on the unmarked connector boot.White deposits were noted on the unmarked connector boot.Abrasions were noted on the silicone tubing of the unmarked connector.The unmarked connector appeared to have been torn at the connector bifurcation.No discontinuities were identified within the returned lead portions.Scanning electron microscopy images of the unmarked connector pin at the opaque appearance region shot that pitting or electro-etching conditions have occurred on the surface of the pin.An energy dispersive spectrometry analysis performed on a sample of the white deposits identified the composition of the substance.No further relevant information has been received to date.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 6925690
• MDR Text Key: 89590445
• Report Number: 1644487-2017-04541
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2002
• Device Model Number: 300-20
• Device Lot Number: 38809C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2000
• 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: 56 YR