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

Model Number 302-20

Device Problems Corroded (1131); Fluid/Blood Leak (1250); Fracture (1260); Mechanical Problem (1384)

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

Event Date 01/01/2017

Event Type  malfunction  

Event Description

A patient underwent a full revision surgery due to a reported high impedance event.The post-op impedance values were reportedly within normal limits.The explanted lead was sent to the manufacturer for product analysis.Analysis has not been completed to date.No further relevant information has been receive to date.

Manufacturer Narrative

The initial report inadvertently stated that the device had not been returned for evaluation when it had actually been returned the day prior (b)(6) 2017).

Manufacturer Narrative

(b)(4).

Event Description

An analysis was performed on the returned lead portion.Gross lead fractures were observed during the gross visual analysis of the returned lead.Scanning electron microscopy was performed on the broken coil strands.One of the broken coil strands was identified as having evidence of a stress induced fracture and the fracture type on the other broken coil strand was unable to be identified due to metal pitting.Abraded openings were found on the outer silicone tubing.These abraded openings and the cut ends made during the explant procedure provided the leakage path for what appeared to be dried remnants of body fluid.Set screw marks were identified and showed evidence that at one point in time a good mechanical and electrical connection was present between the pulse generator and the connector pin.Other than the above, no anomalies were identified on the returned lead portions.

• 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: 6293975
• MDR Text Key: 66273346
• Report Number: 1644487-2017-03113
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2017

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: 06/06/2011
• Device Model Number: 302-20
• Device Lot Number: 200822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/01/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/10/2017; 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2008
• 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: 8 YR