MAUDE Adverse Event Report: CYBERONICS - HOUSTON BIPOL LEAD MODEL 300

Model Number 300-20

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

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

Event Date 10/01/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

A patient was referred for a generator for an unknown reason.After the surgery, it was reported that the patient had high impedance identified.The explanted lead and generator were both sent back to the manufacturer for review.The explanted generator had product analysis completed on 10/31/2016.Per the pa results, the generator performed according to functional specifications and showed the ability to properly measure resistance values.The returned portions of the lead were also analyzed and had analysis completed on 10/31/2016 as well.The set screw marks found on the lead connector pins proved that at one point in time a good mechanical and electrical connection was present.A lead fracture was identified in the connector pin quadfilar coil.Scanning electron microscopy was performed and identified the area on one of the broken coil strands as having evidence of a stress induced fracture.Abraded openings were identified on the lead's outer silicone tubing as well.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6096200
• MDR Text Key: 60093009
• Report Number: 1644487-2016-02611
• 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: Health Professional
• Type of Report: Initial
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2004
• Device Model Number: 300-20
• Device Lot Number: 6055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2002
• 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: 21 YR